TWI767616B - Method for producing embedded or hybrid hydrogel contact lenses - Google Patents

Abstract

The invention is generally related to a method for producing, in a relatively efficient and consistent manner, embedded or hybrid silicone hydrogel contact lenses, and also to unprocessed embedded or hybrid silicone hydrogel contact lenses, according to conventional cast-molding technologies. A method of the invention involve use of a polymeric non-reactive diluent in preparing a polymerizable composition for forming the silicone hydrogel material of the unprocessed embedded or hybrid silicone hydrogel contact lens, which is cast-molded with a lens mold. The unprocessed cast-molded embedded or hybrid silicone hydrogel contact lens has no or a minimal water-swelling degree, so that lens distortion or delamination during the hydration of the unprocessed embedded or hybrid silicone hydrogel contact lens.

Description

Method for producing embedded or hybrid hydrogel contact lenses

The present invention generally relates to a method for producing embedded or hybrid silicone hydrogel contact lenses. In addition, the present invention provides raw embedded hybrid silicone hydrogel contact lenses.

Hydrogel contact lenses are widely used to correct many different types of vision defects due to their softness for wearing comfort. They are made from hydrated, cross-linked polymeric materials containing from about 20% to about 75% by weight of water balanced within the lens polymer matrix. Hydrogel contact lenses are typically produced according to conventional all-cast molding methods. This conventional manufacturing process includes at least the steps of: lens molding (ie, curing the polymerizable composition in a lens mold), demolding (ie, removing the lens from the mold), hydrating the lens, packaging and sterilizing the hydrated lens. During lens hydration, the hydrogel contact lens will absorb water and can typically swell significantly in size.

Typically, each cast-molded silicone hydrogel contact lens adheres to one of the two mold halves of each mold after opening the disposable mold. The adhesion of molded silicone hydrogel contact lenses to the mold halves can be very strong. Forcibly removing (or stripping) the molded lens from the mold halves may cause damage (eg, complete or partial tearing) to the molded lens. Additionally, lenses removed from the mold halves (delivering) may stick to themselves (curling) and will be difficult to handle. Thus, the mold halves with the lenses adhered thereon are extracted with an organic solvent in an extraction tank and then hydrated in water in a hydration tank. Those hydrated lenses are then removed from those mold halves and further processed. Because the mold halves can occupy valuable space in the extraction tank or hydration tank, it is desirable that the molded lens can be removed directly from the mold half to which the lens is attached prior to the extraction and hydration process, thereby increasing product efficiency and yield.

In recent years, it has been proposed that various inserts can be incorporated into hydrogel contact lenses for various purposes, such as for corneal health, vision correction, diagnostics, and the like.參見例如美國專利案號4268132、4401371、5098546、5156726、6851805、7490936、7883207、8154804、8215770、8348424、8874182、9176332、9618773、10203521、和10209534；和美國專利申請公開號20040141150、20040212779、2008/0208335 , 2009/0091818, 20090244477, 2010/0072643, 2010/0076553, 20110157544, 2012/0120365, 2012/01401617, 2012/0234453, 2014/0276481, and 2015/014). Inserts are typically made of non-hydrogel materials that cannot absorb water and are non-water-swellable materials, while hydrogel contact lenses are made of hydrogel materials that typically contain from about 20% by weight to about 75% water and is a water-swellable material. Hybrid hydrogel contact lenses typically consist primarily of a central optic zone of rigid gas permeable (RGP) material and a peripheral zone of hydrogel material. This large difference in water swelling between the insert (or RGP) material and the hydrogel lens material is expected to result in a decrease in the hydrogel contact lens (in which the insert is embedded or in which the RGP material is incorporated) during hydration. Lens distortion or delamination. According to known cast molding processes, it is difficult to produce embedded or hybrid hydrogel contacts.

US Patent No. 10139521 describes a method for making a silicone elastomer-hydrogel hybrid contact lens, the method comprising incorporating an elastomer swellable in a polymerizable composition for forming a lens hydrogel material Monomer to form an anti-delamination bond between the silicone elastomer and the hydrogel material. US Patent No. 10139522 describes a method for making a silicone elastomer-silicone hydrogel hybrid contact lens comprising: incorporating an elastomer swellable monomer into a silicone hydrogel material in the polymerizable composition, thereby forming an anti-delamination bond between the silicone elastomer and the silicone hydrogel material; and changing the amount of crosslinking agent in the polymerizable composition and/or adding a Diluent for silicone to impart low swelling coefficient to silicone hydrogel material. However, the methods of these two patents require the incorporation of elastomeric swellable monomers into the polymerizable composition and are not applicable to hydrogel contact lenses having inserts embedded in the hydrogel contact lenses and made of non- Made of elastomer material.

Accordingly, there remains a need to produce embedded or hybrid silicone hydrogel contact lenses in a manner that is relatively efficient and consistent and that can be easily implemented in a production environment.

In some aspects, the present invention provides a method for producing an embedded silicone hydrogel contact lens or a hybrid silicone hydrogel contact lens, the method of the present invention comprising the steps of: (1) obtaining a method for forming a hydrogel A polymerizable composition of material, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 1% to about 25% by weight of at least one polymeric non-reactive diluent and dissolved in The lens-forming polymerizable material in or blended with the polymeric diluent, wherein the polymerizable material comprises one or more silicone-containing polymerizable components and at least one hydrophilic vinylic monomer, wherein the at least one polymerizable The non-reactive diluent is a poly(C2 _{- C4} alkylene oxide) polymer; (2) an insert or a disc is obtained, wherein the insert is made of a non-hydrogel material, wherein the disc made of a rigid breathable material; (3) obtaining a lens mold, wherein the lens mold comprises a male mold half having a first molding surface and a female mold half having a second molding surface, wherein the male mold half and the female mold half The molds are configured to receive each other such that a mold cavity is formed between the first and second molding surfaces when the mold is closed; (4) the insert or the disc is placed on the lens in no particular order a designated location in the mold and introducing the polymerizable composition into the lens mold, wherein the insert or the disc is dipped into the polymerizable composition in the lens mold; (5) curing the polymerizable composition in the lens mold a polymerizable composition to form a raw insert or hybrid silicone hydrogel contact lens; (6) dividing the lens mold obtained in step (5) into male and female mold halves, wherein the raw insert Or a hybrid silicone hydrogel contact lens is adhered to the lens-adhering mold half, which is one of the male mold half and the female mold half; (7) in the raw embedded silicone hydrogel Remove the raw embedded silicone hydrogel contact lens from the mold half to which the lens adheres before it comes into contact with water or any liquid; and (8) remove the raw embedded or hybrid silicone hydrogel The glue contact lenses are subjected to a post-molding process that includes a hydration process and one or more other processes selected from the group consisting of extraction, surface treatment, packaging, sterilization, and combinations thereof.

In other aspects, the present invention provides a raw embedded silicone hydrogel contact lens or a raw hybrid silicone hydrogel contact lens, which can be produced according to the methods of the present invention.

These and other aspects of the invention will become apparent from the following description of the presently preferred embodiment. The detailed description is merely illustrative of the present invention and does not limit the scope of the present invention, which is defined by the appended claims and their equivalents. As should be apparent to those skilled in the art, many variations and modifications of the present invention can be implemented without departing from the spirit and scope of the novel concepts of the present disclosure.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In general, the nomenclature and laboratory procedures used herein are those well known and commonly used in the art. Conventional methods are used for these procedures, such as those provided in the art and in various general references. When a term is provided in the singular, the inventors also consider the plural of the term. The nomenclature used herein and the laboratory procedures described below are those well known and commonly used in the art.

In this application, "about" as used herein means that a number referred to as "about" includes the recited number plus or minus 1%-10% of that recited number.

"Contact Lens" refers to a structure that can be placed on or inside the wearer's eye. Contact lenses can correct, improve, or alter the user's vision, but they don't have to. Contact lenses may be of any suitable material known in the art or later developed, and may be soft lenses, hard lenses, or embedded lenses.

"Hydrogel Contact Lens" refers to a contact lens comprising a hydrogel body (core) material. The hydrogel bulk material may be a non-silicone hydrogel material or preferably a silicone hydrogel material.

"Hydrogel" or "hydrogel material" refers to a cross-linked polymeric material that has a three-dimensional polymer network (ie, a polymer matrix) that is insoluble in water, but when fully hydrated (or equilibrated) At least 10% by weight of water may be retained in its polymer matrix.

"Silicone hydrogel" or "SiHy" refers to a silicone-containing hydrogel obtained by the copolymerization of a polymerizable composition comprising at least one silicone-containing monomer or at least one silicone-containing Macromer or at least one crosslinkable silicone-containing prepolymer.

Siloxanes, also commonly described as silicones, refer to molecules having at least one -Si-O-Si- moiety in which each Si atom carries two organic groups as substituents.

As used in this application, the terms "non-silicone hydrogel" or "non-silicone hydrogel material" interchangeably refer to a theoretically silicone-free hydrogel.

"SiHy Contact Lens" means a contact lens comprising SiHy bulk (core) material.

"Hybrid SiHy Contact Lens" refers to a contact lens consisting essentially of two zones: a central optic zone made of rigid breathable material; and a peripheral zone, like a skirt, made of SiHy material and surrounding the central optic zone.

"Embedded SiHy contact lens" refers to a SiHy contact lens comprising at least one insert made of a non-hydrogel material and embedded within the bulk SiHy material of the embedded SiHy contact lens.

"Insert" refers to any 3-dimensional article made of a non-hydrogel material and having dimensions of at least 5 microns, but small enough to be embedded in the bulk material of an embedded SiHy contact lens. According to the present invention, the non-hydrogel material may be absorbable less than 10% by weight (preferably about 7.5% or less, more preferably about 5.0% or less, even more preferably about 5.0% or less) when fully hydrated Preferably any material with about 2.5% or less) water. Examples of preferred preferred non-hydrogel materials include, but are not limited to, hard plastics (eg, cross-linked polymethyl methacrylate), breathable materials (eg, cross-linked materials made of fluorosilicone acrylates) , soft plastics, silicone rubber or elastomers (eg, cross-linked silicone polymers), quartz, glass, silicate materials, ceramics, metals, metal oxides, and carbon materials (eg, graphite, or glassy carbon) ).

"Raw Contact Lens" means one obtained by cast-molding a polymerizable composition in a lens mold and not subjected to the post-extraction and/or post-hydration molding process (ie, not mixed with water or any organic solvent or any liquid contact lenses). It should be understood that a raw contact lens can be a raw hydrogel contact lens, a raw SiHy contact lens, a raw embedded hydrogel contact lens, a raw SiHy embedded contact lens, a hybrid hydrogel contact lens , or hybrid SiHy contact lenses.

其中，

表示完全水合的接觸鏡片的直徑，並且

表示未加工的接觸鏡片的直徑。接觸鏡片的直徑係熟知的參數，對每種商業接觸鏡片將其標記並且其典型地是接觸鏡片從邊緣到邊緣的水平直徑。The term "water swellability" in reference to a green contact lens means the diameter of the lens when the green contact lens is fully hydrated (ie, a molded contact lens that has not been in contact with water or any liquid after the molding process). percentage increase. The water swellability ("WSD") of any raw contact lens can be expressed by the following equation

in,

represents the diameter of a fully hydrated contact lens, and

Indicates the diameter of a raw contact lens. The diameter of a contact lens is a well-known parameter that is labeled for each commercial contact lens and is typically the horizontal diameter of the contact lens from edge to edge.

As used herein, "hydrophilic" describes a material or portion thereof that will more readily associate with water than lipids.

"Hydrophobic" means that the insert material or insert has less than 5% (preferably about 4% or less, more preferably about 3% or less, even more preferably about 2% or smaller) equilibrium water content (ie, the water content in a fully hydrated state).

The term "room temperature" refers to a temperature of about 21°C to about 27°C.

The term "soluble" in reference to a compound or material in a solvent means that the compound or material is soluble in the solvent at room temperature to give a solution having a concentration of at least about 0.5% by weight.

The term "insoluble" in reference to a compound or material in a solvent means that the compound or material is soluble in the solvent at room temperature to give a solution having a concentration of less than 0.05% by weight.

"Vinyl monomer" means a compound having a single ethylenically unsaturated group, soluble in a solvent, and polymerizable actinically or thermally.

和/或

）、烯丙基、乙烯基、苯乙烯基或其他含C=C的基團。As used herein, the term "ethylenically unsaturated group" is used herein in a broad sense and is intended to encompass any group containing at least one >C=C< group. Exemplary ethylenically unsaturated groups include, but are not limited to (meth)acryloyl (

and / or

), allyl, vinyl, styryl or other C=C-containing groups.

"Acrylic monomer" means a vinyl monomer having a single (meth)acryloyl group. Examples of acrylic monomers include (meth)acryloxy [or (meth)acryloyloxy] monomers and (meth)acrylamide-based monomers.

或

的一個唯一基團的乙烯類單體。"(meth)acryloyloxy monomer" or "(meth)acryloyloxy monomer" means a monomer having

or

A unique group of vinyl monomers.

或

的一個唯一基團的乙烯類單體，其中R^o 係H或C₁ -C₄ 烷基。"(meth)acrylamido monomer" means a monomer having a

or

A unique group of vinyl monomers, where R ^o is H or C ₁ -C ₄ alkyl.

The term "(meth)acrylamide" refers to methacrylamide and/or acrylamide.

The term "(meth)acrylate" refers to methacrylates and/or acrylates.

）的醯胺化合物。"N-vinylamide monomer" means a vinyl group (

) of amide compounds.

The term "terminal (meth)acryloyl group" refers to a (meth)acryloyl group at one of the two ends of the main chain (or backbone) of an organic compound, as known by those skilled in the art. Known.

As used herein, "actinically" in reference to curing, cross-linking or polymerizing of a polymerizable composition, prepolymer or material means by actinic radiation, such as, for example, UV/visible light irradiation, ionizing radiation (eg, gamma rays or X-ray radiation), microwave irradiation, etc. to cure (eg, cross-link and/or polymerize). Thermal or photochemical curing methods are well known to those skilled in the art.

"ene monomer" refers to a vinyl monomer having a unique alkenyl group.

As used herein, "hydrophilic vinyl monomer", "hydrophilic acrylic monomer", "hydrophilic (meth)acryloyloxy monomer", or "hydrophilic (meth)acrylamido monomer" refers to vinylic monomers, acrylic monomers, (meth)acryloyloxy monomers, or (meth)acrylohydrin, respectively, that typically produce homopolymers that are water soluble or that can absorb at least 10 weight percent water Amine monomers.

As used herein, "hydrophobic vinylic monomer", "hydrophobic acrylic monomer", "hydrophobic (meth)acryloyloxy monomer", or "hydrophobic (meth)acrylamido monomer" Refers to vinylic monomers, acrylic monomers, (meth)acryloyloxy monomers, or (methyl) monomers that typically yield homopolymers that are insoluble in water or can absorb less than 10% by weight of water, respectively. ) acrylamide based monomers.

"Blend vinylic monomer" refers to a vinylic monomer capable of dissolving both the hydrophilic and hydrophobic polymerizable components of the polymerizable composition to form a solution.

"Macromer" or "prepolymer" refers to a compound or polymer that contains ethylenically unsaturated groups and has a number average molecular weight greater than 700 Daltons.

As used herein, the term "vinyl crosslinking agent" refers to an organic compound having at least two ethylenically unsaturated groups. "Ethylene-based cross-linking agent" refers to a vinyl-based cross-linking agent having a molecular weight of 700 Daltons or less.

As used herein, the term "polymer" means a material formed by polymerizing/crosslinking one or more monomers or macromers or prepolymers or combinations thereof.

As used in this application, the term "molecular weight" of polymeric materials (including monomeric or macromonomer materials) refers to number average molecular weight unless specifically indicated otherwise or unless the test conditions indicate otherwise. The skilled person knows how to determine the molecular weight of polymers according to known methods such as GPC (gel permeation chromatography) with one or more of the following: refractive index detectors, small angle laser light scattering detectors, Multi-angle laser light scattering detectors, differential viscometry detectors, UV detectors, and infrared (IR) detectors; MALDI-TOF MS (matrix-assisted desorption/ionization time-of-flight mass spectrometry) ; ¹ H NMR (proton nuclear magnetic resonance) spectroscopy, etc.

，其中R₁ ’和R₂ ’係獨立地選自由以下組成之群組的兩個取代基：C₁ -C₁₀ 烷基、C₁ -C₄ 烷基-或C₁ -C₄ -烷氧基取代的苯基、C₁ -C₁₀ 氟烷基、C₁ -C₁₀ 氟代醚、C₆ -C₁₈ 芳基、-alk-(OC₂ H₄ )_γ1 -OR^o （其中alk係C₁ -C₆ 烷基二基，R^o 係H或C₁ -C₄ 烷基並且γ1係從1至10的整數）、具有至少一個選自由以下組成之群組的官能基的C₂ -C₄₀ 有機基團：羥基（-OH）、羧基（-COOH）、-NR₃ ’R₄ ’、-NR₃ ’-的胺基鍵、-CONR₃ ’-的醯胺鍵、-CONR₃ ’R₄ ’的醯胺、-OCONH-的尿烷鍵、以及C₁ -C₄ 烷氧基，或直鏈親水性聚合物鏈，其中R₃ ’和R₄ ’彼此獨立地是氫或C₁ -C₁₅ 烷基。"Polysiloxane segment" means a polymer chain consisting of at least three consecutive and directly linked siloxane units (divalent groups), each siloxane unit independently of the other having the formula

, wherein R ₁ ' and R ₂ ' are two substituents independently selected from the group consisting of C ₁ -C ₁₀ alkyl, C ₁ -C ₄ alkyl- or C ₁ -C ₄ -alkoxy group-substituted phenyl, C ₁ -C ₁₀ fluoroalkyl, C ₁ -C ₁₀ fluoroether, C ₆ -C ₁₈ aryl, -alk-(OC ₂ H ₄ ) _γ1 -OR ^o (where alk is C ₁ - _C6 alkyl diradical, R ^o is H or C ₁ -C ₄ alkyl and γ1 is an integer from 1 to 10), C ₂ -C having at least one functional group selected from the group consisting of ₄₀ organic groups: hydroxyl (-OH), carboxyl (-COOH), -NR ₃ 'R ₄ ', -NR ₃ '- amide bond, -CONR ₃ '- amide bond, -CONR ₃ 'R ₄ ' amide, -OCONH- urethane bond, and C ₁ -C ₄ alkoxy, or linear hydrophilic polymer chain, wherein R ₃ ' and R ₄ ' are independently of each other hydrogen or C ₁ - C ₁₅ alkyl.

"Polysiloxane vinyl monomer" refers to a compound comprising at least one polysiloxane segment and one unique ethylenically unsaturated group.

"Polysiloxane vinyl crosslinking agent" refers to a compound comprising at least one polysiloxane segment and at least two ethylenically unsaturated groups.

"Linear polysiloxane vinyl crosslinking agent" refers to a compound comprising a main chain comprising at least one polysiloxane segment and being The ethylenically unsaturated groups are capped.

"Chain-extended polysiloxane vinyl crosslinker" means a polysiloxane containing at least two ethylenically unsaturated groups and at least two polysiloxane segments each of which is linked by a divalent group. compound.

的連續地且直接地連接的矽氧烷單元（二價基團）組成的聚合物鏈，其中n1係2或3的整數，R₁ ”、R₂ ”、R₃ ”、和R₄ ”彼此獨立地是C₁ -C₆ 烷基基團（較佳的是甲基）。"Polycarbosiloxane" means a compound containing at least one polycarbosiloxane segment consisting of at least three segments each independently of the other having the formula

A polymer chain consisting of consecutively and directly connected siloxane units (divalent groups), wherein n1 is an integer of 2 or 3, and R ₁ ″, R ₂ ″, R ₃ ″, and R ₄ ″ are each other is independently a _C1 - _C6 alkyl group (preferably methyl).

"Polycarbosiloxane vinyl monomer" refers to a compound comprising at least one polycarbosiloxane segment and a unique ethylenically unsaturated group.

"Polycarbosiloxane vinyl crosslinking agent" refers to a compound comprising at least one polycarbosiloxane segment and at least two ethylenically unsaturated groups.

The term "fluid" as used herein indicates that a material is capable of flowing like a liquid.

As used in this application, with respect to a polymerizable composition, the term "transparent" means that the polymerizable composition is a transparent solution or liquid mixture (ie, having 85% or more in the range between 400 and 700 nm) greater light transmittance).

The term "room temperature" refers to a temperature of about 21°C to about 27°C.

As used in this application, the term "transparent" in reference to a polymerizable composition means that the polymerizable composition is a clear solution or liquid mixture (ie, has 85% or more in the range between 400 and 700 nm large, preferably 90% or more light transmittance).

The term "alkyl" refers to a monovalent group obtained by removing a hydrogen atom from a straight or branched chain alkane compound. An alkyl group (group) forms a bond with one other group in an organic compound.

The terms "alkylene diradical" or "alkylene diradical" or "alkyldiradical" interchangeably refer to a diradical obtained by removing one hydrogen atom from an alkyl group. Alkylene divalent groups form two bonds with other groups in organic compounds.

The term "alkoxy or alkoxyl" refers to a monovalent group obtained by removing a hydrogen atom from the hydroxyl group of a straight or branched chain alkyl alcohol. An alkoxy (group) forms a bond with one other group in an organic compound.

In this application, the term "substituted" in reference to an alkyldiyl or alkyl group means that the alkyldiyl or the alkyl group includes at least one substituent in place of the alkyldiyl group or a hydrogen atom of the alkyl group, and is selected from the group consisting of hydroxyl (-OH), carboxyl (-COOH), -NH ₂ , mercapto (-SH), C ₁ -C ₄ alkyl , C ₁ -C ₄ alkoxy, C ₁ -C ₄ alkylthio (alkyl sulfide), C ₁ -C ₄ acylamino, C ₁ -C ₄ alkylamino, di-C ₁ - _C4 alkylamine groups, and combinations thereof.

Free radical initiators can be photoinitiators or thermal initiators. "Photoinitiator" refers to a chemical that initiates a free radical crosslinking/polymerization reaction by utilizing light. "Thermal initiator" refers to a chemical that initiates a free radical crosslinking/polymerization reaction by utilizing thermal energy.

"Post-curing surface treatment" with respect to SiHy bulk material or SiHy contact lens means the surface treatment process performed after forming the SiHy bulk material or SiHy contact lens by curing (i.e., thermally or actinically polymerizing) the SiHy lens formulation.

"SiHy lens formulation" refers to a polymerizable composition comprising all of the necessary polymerizable components for the production of SiHy contact lenses or SiHy lens bulk materials as known to those skilled in the art.

"Non-optical surface of the mold half" refers to the surface of the mold half that does not come into contact with the lens-forming material during the casting molding of the contact lens.

，其中n係1至5的整數，並且R₁ 、R₂ 和R₃ 彼此獨立地是C₁ -C₈ 烷基或C₁ -C₈ 羥烷基。As used in this application, the term "phosphorocholine" refers to a zwitterionic group

, wherein n is an integer from 1 to 5, and R ₁ , R ₂ and R ₃ are independently of one another C ₁ -C ₈ alkyl or C ₁ -C ₈ hydroxyalkyl.

The intrinsic "oxygen permeability coefficient" Dk _i of a material is the rate at which oxygen passes through the material. The oxygen permeability coefficient is conventionally expressed in units of barrer, where "barrer" is defined as [(cm ³ oxygen)(mm)/(cm ² )(sec)(mm Hg)]×10 ⁻¹⁰ . The oxygen permeability coefficient can be measured according to the procedure described in Example 1.

The "Oxygen Transmission Rate" Dk/t of a lens or material is the rate at which oxygen will pass through a particular lens or material of average thickness t [in mm] over the measured area. Oxygen permeability coefficients are conventionally expressed in units of baler/mm, where "baler/mm" is defined as [(cm ³ oxygen)/(cm ² )(sec)(mm Hg)] x 10 ^-9 .

As used herein, "ophthalmically compatible" refers to a material or material surface that can be in intimate contact with the ocular environment for extended periods of time without significant damage to the ocular environment and without significant user discomfort.

The term "ophthalmically safe" in reference to packaging solutions used to sterilize and store contact lenses means that the contact lenses stored in the solution are safe to place directly on the eye without rinsing after autoclaving, and that the solution is safe and comfortable enough for daily contact with the eye through the contact lens. The ophthalmically safe packaging solution after autoclaving has an eye compatible tonicity and pH and is substantially free of eye irritating or eye cytotoxic materials according to international ISO standards and US FDA regulations.

The term "modulus" or "elastic modulus" in reference to a contact lens or material means the tensile modulus or Young's modulus as a measure of the stiffness of the contact lens or material. Modulus can be measured according to the procedure described in Example 1.

As used in this application, the term "equilibrium water content" in reference to a contact lens or polymeric material means when fully hydrated (equilibrated) in a saline solution (about 0.79 wt% NaCl) and determined at room temperature (as above The amount of water (expressed in weight percent) present in a contact lens or polymeric material when it is defined).

"Aqueous solution" refers to a solution consisting of a homogeneous mixture of water as a solvent and one or more solutes dissolved in the water.

The present invention generally relates to a method for producing embedded SiHy contact lenses each having at least one insert made of a non-hydrogel material in a relatively efficient and consistent manner. The present invention is based in part on the discovery that by using certain polymeric non-reactive diluents in the preparation of SiHy lens formulations (polymerizable compositions) used to make SiHy contact lenses, molding can be controlled during hydration The water swellability of embedded SiHy contact lenses, thereby eliminating or minimizing lens deformation and/or delamination. It is believed that this polymeric non-reactive diluent can remain in the molded SiHy material and can hold spaces that can then be replaced by water during hydration. By controlling the amount of polymeric non-reactive diluent, the degree of water swelling of the molded SiHy embedded contact lenses can be controlled. The present invention is also based, in part, on the discovery that embedded SiHy contact lenses molded from non-reactive diluents with selected polymers can be dry-delivered (ie, free from contact with water or any liquid) removed from lens molds) even when significant (>25 unit parts by weight) polymeric diluents are present in the SiHy lens formulation. It is believed that, unlike organic solvents, the polymeric non-reactive diluents of the present invention do not make the molded SiHy material too soft and brittle so that the molded SiHy contact lens can be removed directly from the lens mold (delivery lens). ). This method of the present invention can be easily implemented in a production environment to increase productivity.

In one aspect, the present invention provides a method for producing embedded silicone hydrogel contact lenses each having at least one insert embedded therein, the method of the present invention comprising the steps of: (1) obtaining a method for forming a silicone A polymerizable composition of a hydrogel material, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 1% to about 25% by weight (preferably from about 2.0% to about 20%, more preferably from about 3.0% to about 17.5%, even more preferably from about 4.0% to about 15%) of at least one polymeric non-reactive diluent and dissolved in the polymeric diluent A polymerizable material in (or blended with) an agent, wherein the polymerizable material comprises (a) at least one silicone-containing vinylic monomer and/or at least one silicone-containing vinylic crosslinking agent and (b) at least one hydrophilic vinylic monomer, wherein the at least one polymeric non-reactive diluent comprises at least one poly(C2 _{- C4} alkylene oxide) polymer; (2) obtaining a lens mold, wherein the lens The mold includes a male mold half having a first molding surface and a female mold half having a second molding surface, wherein the male mold half and the female mold half are configured to receive each other such that when the mold is closed, the mold A cavity is formed between one and the second molding surface; (3) the insert is obtained, wherein the insert is made of a non-hydrogel material; (4) the insert is placed in the lens mold in no particular order and introducing the polymerizable composition into the lens mold, wherein the insert is dipped into the polymerizable composition in the lens mold; (5) curing the polymerizable composition in the lens mold to forming a raw embedded silicone hydrogel contact lens having an insert surrounded by the silicone hydrogel material; (6) separating the lens mold obtained in step (5) into male and female mold halves, wherein the raw embedded silicone hydrogel contact lens is adhered to a lens-adhered mold half, which is one of the male mold half and the female mold half; (7) the raw embedded mold removing the silicone hydrogel contact lens from the mold half to which the lens is attached; and (8) subjecting the raw embedded silicone hydrogel contact lens to a post-molding process comprising a hydration process and one or more selected from Other processes from the group consisting of: extraction, surface treatment, packaging, sterilization, and combinations thereof.

In another aspect, the present invention provides a method for producing hybrid silicone hydrogel contact lenses each consisting essentially of a central optic zone of rigid gas permeable material and a silicone hydrogel surrounding the central optic zone The method of the present invention comprises the following steps: (1) obtaining a polymerizable composition for forming a silicone hydrogel material, wherein the polymerizable composition comprises (relative to the polymerizable composition) total weight) from about 1% to about 25% by weight (preferably from about 2.0% to about 20%, more preferably from about 3.0% to about 17.5%, even more preferably from about 4.0% to about 15%) of at least one polymeric non-reactive diluent and a polymerizable material dissolved in (or blended with) the polymeric diluent, wherein the polymerizable material comprises (a) at least one silicon-containing A ketone vinylic monomer and/or at least one silicone-containing vinylic crosslinking agent and (b) at least one hydrophilic vinylic monomer, wherein the at least one polymeric non-reactive diluent comprises poly(C ₂ -C ₄ alkylene oxide) polymer; (2) obtaining a lens mold, wherein the lens mold comprises a male mold half having a first molding surface and a female mold half having a second molding surface, wherein the male mold The mould halves and the female mould halves are configured to receive each other such that when the mould is closed a mould cavity is formed between the first and second moulding surfaces; (3) a disc is obtained, wherein the disc is made of a rigid gas permeable material be made and have a first surface matching the central area of the first molding surface and an opposing second surface matching the central area of the second molding surface; (4) in no particular order, the insert The object or the disc is placed in a designated position in the lens mold, and the polymerizable composition is introduced into the lens mold, wherein the disc is surrounded by the first and second molding surfaces and the polymerizable composition in the lens mold composition surround; (5) curing the polymerizable composition in the lens mold to form a raw hybrid silicone hydrogel contact lens consisting essentially of a central optic zone of rigid gas permeable material and surrounding the central optic (6) dividing the lens mold obtained in step (5) into male and female mold halves, wherein the raw hybrid silicone hydrogel contact lens adheres on the lens-attached mold half, which is one of the male mold half and the female mold half; (7) removing the raw hybrid silicone hydrogel contact lens from the lens-attached mold half and (8) subjecting the raw hybrid silicone hydrogel contact lens to a post-molding process that includes a hydration process and one or more other processes selected from the group consisting of extraction, surface treatment, Packaging, sterilization, and combinations thereof.

）的二價基團；PO係環氧丙烷（

）的二價基團；BO係環氧丁烷（

）的二價基團；m1係零或從5至65的整數；n1係零或從5至52的整數；p1係零或從5至30的整數；其中，如果n1不是零，則p1係零；其中，如果p1不是零，則n1係零且m1不是零；其中（m1+n1+p1）係提供具有以下數目平均分子量的該聚(C₂ -C₄ 伸烷基氧化物)聚合物的值：從約300至約3000道耳頓（較佳的是從約400至約2500道耳頓、更較佳的是從約400至約2000道耳頓、甚至更較佳的是從約400至約1500道耳頓）。According to the present invention, poly(C ₂ -C ₄ alkylene oxide) polymers refer to polymers of R ₁ -O-(EO) _m1 (PO) _n1 (BO) _p1 -R ₂ , wherein: R ₁ and R ₂ are independently of each other hydrogen or C ₁ -C ₄ alkyl (preferably hydrogen or methyl); EO is ethylene oxide (

) of the divalent group; PO series propylene oxide (

) of the divalent group; BO series butylene oxide (

); m1 is zero or an integer from 5 to 65; n1 is zero or an integer from 5 to 52; p1 is zero or an integer from 5 to 30; wherein, if n1 is not zero, then p1 is zero; where, if p1 is not zero, then n1 is zero and m1 is not zero; where (m1+n1+p1) is to provide the poly(C2 _{- C4alkylene} oxide) polymer having the following number average molecular weight Value: from about 300 to about 3000 daltons (preferably from about 400 to about 2500 daltons, more preferably from about 400 to about 2000 daltons, even more preferably from about 400 to about 1500 Daltons).

Examples of preferred preferred poly(C2 _{- C4} alkylene oxide) polymers include poly(ethylene oxide) ("PEO"), poly(propylene oxide) ("PPO"), poly(ethylene oxide) ("PEO"), poly(ethylene oxide) (ethylene oxide)-poly(propylene oxide) diblock copolymer (“PEO-PPO”), poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) triblock block copolymer ("PEO-PPO-PEO"), poly(propylene oxide)-poly(ethylene oxide)-poly(propylene oxide) triblock copolymer ("PPO-PEO-PPO"), poly(propylene oxide) (ethylene oxide)-poly(butylene oxide) diblock copolymer (“PEO-PBO”), poly(ethylene oxide)-poly(butylene oxide)-poly(ethylene oxide) Triblock copolymer ("PEO-PBO-PEO"), poly(butylene oxide)-poly(ethylene oxide)-poly(butylene oxide) triblock copolymer ("PBO-PEO-PBO ”), and mixtures thereof. Those preferred poly(C2 _{- C4} alkylene oxide) polymers, such as PEO, PPO, PEO-PPO, PEO-PPO-PEO and PPO-PEO-PPO, are available from commercial sources or Synthesized according to known methods. PEO-PBO, PEO-PBO-PEO and PBO-PEO-PBO can be synthesized according to the procedures described in US Patent No. 8,318,144.

The amount of polymeric non-reactive diluent in the polymerizable composition is sufficient to provide from about -7% to about 7% (preferably from about -5% to about 5%, More preferred is a water swellability of from about -3% to about 3%, even more preferably from about -1% to about 1%).

According to a preferred embodiment, in addition to the polymeric non-reactive diluent, the polymerizable composition comprises less than 10% by weight (preferably about 7.5% or less, more preferably about 5.0% or less by weight) less, even more preferably, about 2.5% or less) of any non-reactive diluent. According to the present invention, the organic solvent may be a non-reactive diluent other than the polymer non-reactive diluent. The term "non-reactive diluent" refers to a chemical or material that is liquid at room temperature and capable of participating in free radical polymerization reactions.

Examples of preferred preferred organic solvents include, but are not limited to, tetrahydrofuran, tripropylene glycol methyl ether, dipropylene glycol methyl ether, ethylene glycol n-butyl ether, ketones (such as acetone, methyl ethyl ketone, etc.), dipropylene glycol Ethylene glycol n-butyl ether, diethylene glycol methyl ether, ethylene glycol phenyl ether, propylene glycol methyl ether, propylene glycol methyl ether acetate, dipropylene glycol methyl ether acetate, propylene glycol n-propyl ether, Dipropylene glycol n-propyl ether, tripropylene glycol n-butyl ether, propylene glycol n-butyl ether, dipropylene glycol n-butyl ether, tripropylene glycol n-butyl ether, propylene glycol phenyl ether, dipropylene glycol dimethyl ether, polyethylene glycol , polypropylene glycol, ethyl acetate, butyl acetate, amyl acetate, methyl lactate, ethyl lactate, isopropyl lactate, dichloromethane, 2-butanol, 1-propanol, 2-propanol, menthol , cyclohexanol, cyclopentanol and exonorborneol, 2-pentanol, 3-pentanol, 2-hexanol, 3-hexanol, 3-methyl-2-butanol, 2-heptanol , 2-octanol, 2-nonanol, 2-decanol, 3-octanol, norbornol, tertiary butanol, tertiary pentanol, 2-methyl-2-pentanol, 2,3-dimethyl alcohol yl-2-butanol, 3-methyl-3-pentanol, 1-methylcyclohexanol, 2-methyl-2-hexanol, 3,7-dimethyl-3-octanol, 1- Chloro-2-methyl-2-propanol, 2-methyl-2-heptanol, 2-methyl-2-octanol, 2-2-methyl-2-nonanol, 2-methyl-2 - Decanol, 3-methyl-3-hexanol, 3-methyl-3-heptanol, 4-methyl-4-heptanol, 3-methyl-3-octanol, 4-methyl-4 -Octanol, 3-methyl-3-nonanol, 4-methyl-4-nonanol, 3-methyl-3-octanol, 3-ethyl-3-hexanol, 3-methyl-3 -Heptanol, 4-ethyl-4-heptanol, 4-propyl-4-heptanol, 4-isopropyl-4-heptanol, 2,4-dimethyl-2-pentanol, 1- Methylcyclopentanol, 1-ethylcyclopentanol, 1-ethylcyclopentanol, 3-hydroxy-3-methyl-1-butene, 4-hydroxy-4-methyl-1-cyclopentanol , 2-phenyl-2-propanol, 2-methoxy-2-methyl-2-propanol, 2,3,4-trimethyl-3-pentanol, 3,7-dimethyl- 3-octanol, 2-phenyl-2-butanol, 2-methyl-1-phenyl-2-propanol and 3-ethyl-3-pentanol, 1-ethoxy-2-propanol, 1-methyl-2-propanol, tertiary pentanol, isopropanol, 1-methyl-2-pyrrolidone, N,N-dimethylpropionamide, dimethylformamide, dimethyl acetamide, dimethylpropionamide, N-methylpyrrolidone, and mixtures thereof. More preferred preferred organic solvents include but are not limited to methanol, ethanol, 1-propanol, isopropanol, secondary butanol, tertiary butanol, tertiary amyl alcohol, acetone, methyl ethyl ketone, methyl ethyl ketone, methyl alcohol isopropyl ketone, methyl propyl ketone, ethyl acetate, heptane, methyl hexane (various isomers), methylcyclohexane, dimethylcyclopentane (various isomers), 2 , 2,4-trimethylpentane, and mixtures thereof.

According to the present invention, any suitable silicone-containing polymerizable component may be used in the present invention. Silicone-containing polymerizable components are well known to those skilled in the art, have been reported in patents and patent applications published as of the filing date of this application, and have been used to produce commercial SiHy contact lenses. Examples of commercial SiHy contact lenses include, but are not limited to, asmofilcon A, balafilcon A, comfilcon A, delefilcon A, efrofilcon A, enfilcon A, fanfilcon A, galyfilcon A, lotrafilcon A, lotrafilcon B, narafilcon A, narafilcon B, senofilcon A, senofilcon B, senofilcon C, smafilcon A, somofilcon A, and stenfilcon A. Examples of suitable silicone-containing polymerizable components include, but are not limited to, silicone-containing vinylic monomers and silicone-containing vinylic crosslinking agents.

Examples of preferred preferred silicone-containing vinylic monomers include, but are not limited to, bis(trialkylsilyloxy)alkylsilyl or tris(trialkylsilyloxy)silyl groups each. Vinyl monomer, polysiloxane vinyl monomer, polycarbosiloxane vinyl monomer, 3-methacrylooxypropyl pentamethyldisiloxane, tertiary butyldimethyl- Siloxyethylvinylcarbonate, trimethylsilylethylvinylcarbonate, and trimethylsilylmethylvinylcarbonate, and combinations thereof.

Examples of preferred preferred vinyl monomers each having a bis(trialkylsilyloxy)alkylsilyl group or a tris(trialkylsilyloxy)silyl group include, but are not limited to, (methyl) Tris(trimethylsilyloxy)silylpropyl acrylate, [3-(meth)acryloyloxy-2-hydroxypropoxy]propylbis(trimethylsilyloxy)methylsilane, [3-(Meth)acryloyloxy-2-hydroxypropoxy]propylbis(trimethylsilyloxy)butylsilane, 3-(meth)acryloyloxy-2-(2- Hydroxyethoxy)-propoxy)propylbis(trimethylsilyloxy)methylsilane, 3-(meth)acryloyloxy-2-hydroxypropoxy)propyltris(trimethyl) Siloxy) silane, N-[tris(trimethylsiloxy)silylpropyl]-(meth)acrylamide, N-(2-hydroxy-3-(3-(bis(trimethyl) Silyloxy)methylsilyl)propoxy)propyl)-2-methyl(meth)acrylamide, N-(2-hydroxy-3-(3-(bis(trimethylsilyl)) Oxy)methylsilyl)propoxy)propyl)(meth)acrylamide, N-(2-hydroxy-3-(3-(tris(trimethylsilyloxy)silyl)propyl) oxy)propyl)-2-methacrylamide, N-(2-hydroxy-3-(3-(tris(trimethylsilyloxy)silyl)propoxy)propyl)(methylsilyloxy) base) acrylamide, N-[tris(dimethylpropylsilyloxy)silylpropyl]-(meth)acrylamide, N-[tris(dimethylphenylsilyloxy)silyl Propyl](meth)acrylamide, N-[tris(dimethylethylsiloxy)silylpropyl](meth)acrylamide, N,N-bis[2-hydroxy-3- (3-(Bis(trimethylsilyloxy)methylsilyl)propoxy)propyl]-2-methyl(meth)acrylamide, N,N-bis[2-hydroxy-3 -(3-(Bis(trimethylsilyloxy)methylsilyl)propoxy)propyl](meth)acrylamide, N,N-bis[2-hydroxy-3-(3- (Tris(trimethylsilyloxy)silyl)propoxy)propyl]-2-methyl(meth)acrylamide, N,N-bis[2-hydroxy-3-(3-( Tris(trimethylsilyloxy)silyl)propoxy)propyl](meth)acrylamide, N-[2-hydroxy-3-(3-(tertiarybutyldimethylsilyl) ) propoxy) propyl]-2-methyl (meth) acrylamide, N-[2-hydroxy-3-(3-(tertiary butyldimethylsilyl) propoxy) propyl ] (meth)acrylamide, N,N-bis[2-hydroxy-3-(3-(tertiarybutyldimethylsilyl)propoxy)propyl]-2-methyl(methyl) ) acrylamide, N-2-(meth)acryloyloxyethyl-O-(methyl-bis-trimethylsilyloxy-3-propyl)silylcarbamate, 3- (Trimethylsilyl)propylvinylcarbamate, 3-(vinyloxycarbonylthio)propyl-tris(trimethyl-silyloxy)silane, 3-[tris(trimethyl) silyloxy)silyl]propylvinylcarbamate, 3-[tris(trimethylsiloxy)silyl]propylene Propyl carbamate, 3-[tris(trimethylsiloxy)silyl]propyl vinyl carbonate, those disclosed in US Pat. Nos. 9,097,840, 9,103,965 and 9,475,827, and mixtures thereof. The above preferred preferred silicone-containing vinylic monomers can be obtained from commercial suppliers or can be prepared according to the procedures described in US Pat.

Examples of preferred preferred polysiloxane vinyl monomers include, but are not limited to, mono-(meth)acryloyl-terminated, monoalkyl-terminated polysiloxanes of formula (I), It includes, but is not limited to, α-(meth)acryloyloxypropyl terminated ω-butyl (or ω-methyl) terminated polydimethylsiloxane, α-(meth)acryloyloxy -2-hydroxypropoxypropyl terminated omega-butyl (or omega-methyl) terminated polydimethylsiloxane, α-(2-hydroxy-methacryloyloxypropoxypropyl) )-ω-butyl-decamethylpentasiloxane, α-[3-(meth)acryloyloxyethoxy-2-hydroxypropoxypropyl]-terminated ω-butyl (or ω-methyl)-terminated polydimethylsiloxane, α-[3-(meth)acryloyloxy-propoxy-2-hydroxypropoxypropyl]-terminated ω-butyl ( or ω-methyl) terminated polydimethylsiloxane, α-[3-(meth)acryloyloxyisopropoxy-2-hydroxypropoxypropyl]-terminated ω-butyl (or omega-methyl) terminated polydimethylsiloxane, α-[3-(meth)acryloyloxybutoxy-2-hydroxypropoxypropyl]-terminated omega-butyl (or omega-methyl) terminated polydimethylsiloxane, α-[3-(meth)acryloyloxyethylamino-2-hydroxypropoxypropyl]-terminated omega-butane (or omega-methyl) terminated polydimethylsiloxane, α-[3-(meth)acryloyloxypropylamino-2-hydroxypropoxypropyl]-terminated omega- Butyl (or omega-methyl) terminated polydimethylsiloxane, α-[3-(meth)acryloyloxy-butylamino-2-hydroxypropoxypropyl]-terminated ω-butyl (or ω-methyl) terminated polydimethylsiloxane, α-(meth)acryloyloxy (polyvinyloxy)-2-hydroxypropoxypropyl]-terminated omega-butyl (or omega-methyl) terminated polydimethylsiloxane, α-[(meth)acryloyloxy-2-hydroxypropoxy-ethoxypropyl]-terminated omega -Butyl (or omega-methyl) terminated polydimethylsiloxane, α-[(meth)acryloyloxy-2-hydroxypropyl-N-ethylaminopropyl]-terminated ω-butyl (or ω-methyl) terminated polydimethylsiloxane, α-[(meth)acryloyloxy-2-hydroxypropyl-aminopropyl]-terminated ω-butyl (or omega-methyl) terminated polydimethylsiloxane, α-[(meth)acryloyloxy-2-hydroxypropoxy-(polyvinyloxy)propyl]-terminated omega -Butyl (or omega-methyl) terminated polydimethylsiloxane, α-(meth)acryloylaminopropoxypropyl terminated omega-butyl (or omega-methyl) capped Terminated polydimethylsiloxane, α-N-methyl-(meth)acryloylaminopropoxypropyl terminated omega-butyl (or omega-methyl) terminated polydimethylsiloxane Oxane, α-[3-(Meth)acrylamidoethoxy-2-hydroxypropoxy-propyl]-terminated ω-butyl (or ω-methyl)polydimethylsiloxane Alkane, α-[3-(meth)acrylamidopropoxy-2- Hydroxypropoxypropyl]-terminated omega-butyl (or omega-methyl) terminated polydimethylsiloxane, α-[3-(meth)acrylamidoisopropoxy-2 -Hydroxypropoxypropyl]-terminated omega-butyl (or omega-methyl) terminated polydimethylsiloxane, α-[3-(meth)acrylamidobutoxy-2 -Hydroxypropoxypropyl]-terminated ω-butyl (or ω-methyl) terminated polydimethylsiloxane, α-[3-(meth)acrylamido-2-hydroxypropyl oxypropyl] terminated ω-butyl (or ω-methyl) polydimethylsiloxane, α-[3-[N-methyl-(meth)acrylamido]-2-hydroxy Propoxypropyl]-terminated omega-butyl (or omega-methyl) terminated polydimethylsiloxane, N-methyl-N'-(propyltetrakis(dimethylsilyloxy)dimethicone) Methylbutylsilane) (meth)acrylamide, N-(2,3-dihydroxypropane)-N'-(propyltetrakis(dimethylsiloxy)dimethylbutylsilane)(methyl) yl) acrylamide, (meth)acrylamidopropyltetrakis(dimethylsiloxy)dimethylbutylsilane, mono-vinylcarbonate-terminated mono-alkyl-terminated polydiethylene Methylsiloxanes, mono-vinylcarbamate-terminated mono-alkyl-terminated polydimethylsiloxanes, those disclosed in U.S. Patent Nos. 9,097,840 and 9,103,965 (and mixtures thereof) . The above preferred preferred polysiloxane vinyl monomers can be obtained from commercial suppliers (eg, Shin-Etsu, Gelest, etc.), or according to patents such as US Pat. Prepared by the procedures described in Case Nos. 6867245, 8415405, 8475529, 8614261, and 9217813, or by coupling reactions well known to those skilled in the art by making hydroxyalkyl (meth)acrylates or hydroxyalkyl(meth)acrylamides Reaction of amine or (meth)acrylooxypolyethylene glycol with mono-glycidoxypropyl-terminated polydimethylsiloxane by combining glycidyl (meth)acrylate with mono- methanol-terminated polydimethylsiloxane, mono-aminopropyl-terminated polydimethylsiloxane, or mono-ethylaminopropyl-terminated polydimethylsiloxane reaction, Or obtained by reacting isocyanatoethyl (meth)acrylate with mono-methanol-terminated polydimethylsiloxane.

Examples of preferred preferred polycarbosiloxane vinylic monomers include, but are not limited to, those disclosed in US Pat. Nos. 7,915,323 and 8,420,711 and US Patent Application Publication Nos. 2012/244088 A1 and 2012/245249 A1.

Examples of preferred preferred silicone-containing vinylic crosslinking agents include, but are not limited to, polysiloxane vinylic crosslinking agents, polycarbosiloxane vinylic crosslinking agents, and combinations thereof.

Preferred examples of preferred polysiloxane vinyl crosslinking agents are di-(meth)acryloyl terminated polydimethylsiloxane; divinyl carbonate terminated polydimethylsiloxane alkane; divinylcarbamate-terminated polydimethylsiloxane; N,N,N',N'-tetrakis(3-methacryloyloxy-2-hydroxypropyl)-α, ω-bis-3-aminopropyl-polydimethylsiloxane; selected from macromonomer A, macromonomer B, macromonomer C and macromonomer D as described in US 5,760,100 Polysiloxane-containing macromonomers of the group consisting of; 4684538、4703097、4833218、4837289、4954586、4954587、5010141、5034461、5070170、5079319、5039761、5346946、5358995、5387632、5416132、5451617、5486579、5962548、5981675、6039913以及6762264中的含聚矽氧烷的大Molecular monomers; polysiloxane-containing macromers disclosed in US Pat. Nos. 4,259,467, 4,260,725 and 4,261,875.

Examples of preferred preferred di-(meth)acryloyloxy-terminated polysiloxane vinyl crosslinkers include, but are not limited to, glycidyl methacrylate and di-amino-terminated polydi- Reaction product of methylsiloxane; reaction product of glycidyl methacrylate with di-hydroxy-terminated polydimethylsiloxane; isocyanatoethyl (meth)acrylate with di-hydroxy-terminated polydimethylsiloxane The reaction product of terminated polydimethylsiloxane; as disclosed in U.S. Patent No. 10081697 bis-(meth)acryloyloxy terminated polysiloxane ethylene-based crosslinking agents each having Hydrophilized siloxane units each having a methyl substituent and a monovalent _C4 - _C40 organic group substituent having 2 to 6 hydroxyl groups; disclosed in US 201008843 A1 and Chain-extended polysiloxane vinyl-based crosslinking agents in US 20120088844 A1; chain-extended polysiloxane vinyl-based cross-linking agents described in US Pat. ; Chain-extended polysiloxane ethylene-based crosslinkers described in US Patent Application Publication No. 2018-0100053; Chain-extended polysiloxane ethylene-based crosslinkers described in US Patent Application Publication No. 2018-0100038 ; chain-extended polysiloxane vinyl crosslinkers described in US 8993651; α,ω-bis[3-(meth)acrylamidopropyl]-terminated polydimethylsiloxane, α,ω-Bis[3-(meth)acryloyloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloyloxy-2-hydroxyl Propoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloyloxyethoxy-2-hydroxypropoxypropyl]-terminated poly Dimethiconol, α,ω-bis[3-(meth)acryloyloxypropoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω - Bis[3-(meth)acryloyloxy-isopropoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(methyl) ) acryloxybutoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamidoethoxy-2 -Hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamidopropoxy-2-hydroxypropoxypropyl]-capped Terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamidoisopropoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-Bis[3-(meth)acrylamidobutoxy-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(methyl) base) acryloxyethylamino-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloyloxy Propylamino-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloyloxybutylamino-2-hydroxypropyl] Oxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acrylamidoethylamino-2-hydroxypropoxy-propyl]-terminated polydimethicone Methylsiloxane, α,ω-bis[3-(meth)acrylamidopropylamino-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω - Bis[3-(meth)acrylamido-butylamino-2-hydroxypropoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloylamide Oxy-2-hydroxypropoxy-ethoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloyloxy-2-hydroxypropyl-N- Ethylaminopropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloyloxy-2-hydroxypropyl-aminopropyl]-polydimethylsiloxane Oxane, α,ω-bis[(meth)acryloyloxy-2-hydroxypropoxy-(polyvinyloxy)propyl]-terminated polydimethylsiloxane, α,ω-bis [(Meth)acryloyloxyethylamino-carbonyloxy-ethoxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloyloxyethyl amino-carbonyloxy-(polyvinyloxy)propyl]-terminated polydimethylsiloxane.

Examples of preferred preferred polycarbosiloxane vinylic crosslinking agents include, but are not limited to, those disclosed in US Pat. Nos. 7,915,323 and 8,420,711 and US Patent Application Publication Nos. 2012/0244088 and 2012/0245249.

According to the present invention, any suitable hydrophilic vinylic monomer may be used in the present invention. Various hydrophilic vinylic monomer systems are well known to those skilled in the art, have been reported in patents and patent applications published as of the filing date of this application, and have been used to produce commercial SiHy contact lenses as described above.

Examples of preferred preferred hydrophilic vinylic monomers are alkyl(meth)acrylamides (as described below), hydroxyl-containing acrylic monomers (as described below), amine-containing acrylics monomers (as described below), carboxyl-containing acrylic monomers (as described below), N-vinylamide monomers (as described below), methylene-containing pyrrolidone monomers (as described below) That is, pyrrolidone derivatives each having a methylene group attached to the pyrrolidone ring at the 3 or 5 position) (as described below), acrylics having a C ₁ -C ₄ alkoxyethoxy group Monomers (as described below), vinyl ether monomers (as described below), allyl ether monomers (as described below), phosphocholine-containing vinyl monomers (as described below) , N-2-hydroxyethyl vinyl carbamate, N-carboxyvinyl-beta-alanine (VINAL), N-carboxyvinyl-alpha-alanine, and combinations thereof.

Examples of alkyl(meth)acrylamides include, but are not limited to (meth)acrylamides, N,N-dimethyl(meth)acrylamides, N-ethyl(meth)acrylamides, N,N-Diethyl (meth)acrylamide, N-propyl (meth)acrylamide, N-isopropyl (meth)acrylamide, N-3-methoxypropyl ( Meth)acrylamides, and combinations thereof.

Examples of hydroxyl-containing acrylic monomers include, but are not limited to, N-2-hydroxyethyl(meth)acrylamide, N,N-bis(hydroxyethyl)(meth)acrylamide, N-3- Hydroxypropyl (meth) acrylamide, N-2-hydroxypropyl (meth) acrylamide, N-2,3-dihydroxypropyl (meth) acrylamide, N -tris (hydroxymethyl) base) methyl (meth) acrylamide, 2-hydroxyethyl (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, glycerol methacrylate (GMA), di(ethylene glycol)(meth)acrylate, tri(ethylene glycol)(meth)acrylate, tetra(ethylene glycol)(meth)acrylate, with number average up to 1500 Molecular weight poly(ethylene glycol)(meth)acrylates, poly(ethylene glycol)ethyl(meth)acrylamides having number average molecular weights up to 1500, and combinations thereof.

Examples of amine group-containing acrylic monomers include, but are not limited to, N-2-aminoethyl(meth)acrylamide, N-2-methylaminoethyl(meth)acrylamide, N- 2-Ethylaminoethyl (meth)acrylamide, N-2-dimethylaminoethyl (meth)acrylamide, N-3-aminopropyl (meth)acrylamide , N-3-methylaminopropyl (meth)acrylamide, N-3-dimethylaminopropyl (meth)acrylamide, 2-aminoethyl (meth)acrylate , 2-methylaminoethyl (meth)acrylate, 2-ethylaminoethyl (meth)acrylate, 3-aminopropyl (meth)acrylate, 3 (meth)acrylate -Methylaminopropyl, 3-ethylaminopropyl (meth)acrylate, 3-amino-2-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (methyl) Trimethylammonium 2-hydroxy propyl (meth)acrylate hydrochloride, dimethylaminoethyl (meth)acrylate, and combinations thereof.

Examples of carboxyl-containing acrylic monomers include, but are not limited to, 2-(meth)acrylamidoglycolic acid, (meth)acrylic acid, ethacrylic acid, and combinations thereof.

Examples of preferred preferred N-vinylamide monomers include, but are not limited to, N-vinylpyrrolidone (also known as N-vinyl-2 - pyrrolidone), N-vinyl-3- Methyl-2-pyrrolidone, N-vinyl-4-methyl-2-pyrrolidone, N-vinyl-5-methyl-2-pyrrolidone, N-vinyl-6-methyl -2-pyrrolidone, N-vinyl-3-ethyl-2-pyrrolidone, N-vinyl-4,5-dimethyl-2-pyrrolidone, N-vinyl-5,5 -Dimethyl-2-pyrrolidone, N-vinyl-3,3,5-trimethyl-2-pyrrolidone, N-vinylpiperidone (also known as, N-vinyl-2- piperidinone), N-vinyl-3-methyl-2-piperidinone, N-vinyl-4-methyl-2-piperidinone, N-vinyl-5-methyl-2-piperidone Iridone, N-vinyl-6-methyl-2-piperidinone, N-vinyl-6-ethyl-2-piperidinone, N-vinyl-3,5-dimethyl-2- piperidinone, N-vinyl-4,4-dimethyl-2-piperidinone, N-vinylcaprolactam (also known as, N-vinyl-2-caprolactam), N- Vinyl-3-methyl-2-caprolactam, N-vinyl-4-methyl-2-caprolactam, N-vinyl-7-methyl-2-caprolactam, N -Vinyl-7-ethyl-2-caprolactam, N-vinyl-3,5-dimethyl-2-caprolactam, N-vinyl-4,6-dimethyl-2 -Caprolactam, N-vinyl-3,5,7-trimethyl-2-caprolactam, N-vinyl-N-methylacetamide, N-vinylformamide, N - Vinylacetamide, N-vinylisopropylamide, N-vinyl-N-ethylacetamide, N-vinyl-N-ethylformamide, and mixtures thereof. Preferably, the N-vinylamide monomer system is N-vinylpyrrolidone, N-vinyl-N-methylacetamide, or a combination thereof.

Examples of preferred preferred methylene-containing (=CH ₂ ) pyrrolidone monomers include, but are not limited to, 1-methyl-3-methylene-2-pyrrolidone, 1-ethyl-3 -Methylene-2-pyrrolidone, 1-methyl-5-methylene-2-pyrrolidone, 1-ethyl-5-methylene-2-pyrrolidone, 5-methyl- 3-Methylene-2-pyrrolidone, 5-ethyl-3-methylene-2-pyrrolidone, 1-n-propyl-3-methylene-2-pyrrolidone, 1-n-propyl Propyl-5-methylene-2-pyrrolidone, 1-isopropyl-3-methylene-2-pyrrolidone, 1-isopropyl-5-methylene-2-pyrrolidone , 1-n-butyl-3-methylene-2-pyrrolidone, 1-tertiarybutyl-3-methylene-2-pyrrolidone, and combinations thereof.

Examples of preferred preferred acrylic monomers having C ₁ -C ₄ alkoxyethoxy groups include, but are not limited to, ethylene glycol methyl ether (meth)acrylate, di(ethylene glycol) methyl Ether (meth)acrylate, tris(ethylene glycol) methyl ether (meth)acrylate, tetra(ethylene glycol) methyl ether (meth)acrylate, C with weight average molecular weight up to 1500 ₁ - _C4 -alkoxy poly(ethylene glycol)(meth)acrylates, methoxy-poly(ethylene glycol)ethyl(meth)acrylamides with number average molecular weights up to 1500, and its combinations.

Examples of preferred preferred vinyl ether monomers include, but are not limited to, ethylene glycol monovinyl ether, di(ethylene glycol) monovinyl ether, tri(ethylene glycol) monovinyl ether, tetra(ethylene glycol) monovinyl ether diol) monovinyl ether, poly(ethylene glycol) monovinyl ether, ethylene glycol methyl vinyl ether, di(ethylene glycol) methyl vinyl ether, tri(ethylene glycol) methyl vinyl ether ether, tetra(ethylene glycol) methyl vinyl ether, poly(ethylene glycol) methyl vinyl ether, and combinations thereof.

Examples of preferred preferred allyl ether monomers include, but are not limited to, allyl alcohol, ethylene glycol monoallyl ether, di(ethylene glycol) monoallyl ether, tri(ethylene glycol) Monoallyl ether, tetra(ethylene glycol) monoallyl ether, poly(ethylene glycol) monoallyl ether, ethylene glycol methallyl ether, di(ethylene glycol) methallyl ether, tri(ethylene glycol) methallyl ether, tetra(ethylene glycol) methallyl ether, poly(ethylene glycol) methallyl ether, and combinations thereof.

Examples of preferred preferred phosphorocholine-containing vinylic monomers include, but are not limited to (meth)acryloyloxyethylphosphorocholine (also known as, MPC, or 2-((methyl) Acryloyloxy)ethyl-2'-(trimethylammonio)ethyl phosphate), (meth)acrylooxypropylphosphorylcholine (also known as, 3-((meth)propene) Ethyloxy)propyl-2'-(trimethylammonio)ethyl phosphate), 4-((meth)acryloyloxy)butyl-2'-(trimethylammonio)ethyl Phosphate, 2-[(Meth)acrylamido]ethyl-2'-(trimethylammonio)-ethyl phosphate, 3-[(meth)acrylamido]propyl -2'-(trimethylammonio)ethyl phosphate, 4-[(meth)acryloylamino]butyl-2'-(trimethylammonio)ethyl phosphate, 5-( (Meth)acryloyloxy)pentyl-2'-(trimethylammonio)ethyl phosphate, 6-((meth)acryloyloxy)hexyl-2'-(trimethylammonio) )-ethyl phosphate, 2-(((meth)acryloyloxy)ethyl-2'-(triethylammonio)ethyl phosphate, 2-((meth)acryloyloxy)ethyl 2'-(tripropylammonio)ethyl phosphate, 2-((meth)acryloyloxy)ethyl-2'-(tributylammonio)ethyl phosphate, 2-((meth)acryloyloxy)ethyl-2'-(tributylammonio)ethyl phosphate (Meth)acryloyloxy)propyl-2'-(trimethylammonio)-ethyl phosphate, 2-((meth)acryloyloxy)butyl-2'-(trimethyl) Ammonio)ethyl phosphate, 2-((meth)acryloyloxy)pentyl-2'-(trimethylammonio)ethyl phosphate, 2-((meth)acryloyloxy) Hexyl-2'-(trimethylammonio)ethyl phosphate, 2-(vinyloxy)ethyl-2'-(trimethylammonio)ethyl phosphate, 2-(allyloxy) ) ethyl-2'-(trimethylammonio)ethyl phosphate, 2-(vinyloxycarbonyl)ethyl-2'-(trimethylammonio)ethyl phosphate, 2-(ene) Propoxycarbonyl)ethyl-2'-(trimethylammonio)-ethyl phosphate, 2-(vinylcarbonylamino)ethyl-2'-(trimethylammonio)ethyl phosphate , 2-(allyloxycarbonylamino)ethyl-2'-(trimethylammonio)ethyl phosphate, 2-(butenyloxy)ethyl-2'-(trimethyl) Ammonium) ethyl phosphate, and combinations thereof.

As known to those skilled in the art, SiHy contact lens formulations may also contain other essential components known to those skilled in the art, such as, for example, non-silicone vinylic crosslinkers, hydrophobic vinylic monomers, UV absorbing vinyl monomers, HEVL absorbing vinyl monomers, visibility colorants (eg, such as reactive dyes, polymerizable dyes, pigments, or mixtures thereof well known to those skilled in the art), antimicrobial agents ( For example, preferred are silver nanoparticles), bioactive agents, leachable lubricants, leachable tear stabilizers, and mixtures thereof.

Examples of preferred preferred non-silicone vinylic crosslinking agents include, but are not limited to, ethylene glycol di-(meth)acrylate, diethylene glycol di-(meth)acrylate, triethylene glycol di-(meth)acrylate -(meth)acrylate, tetraethylene glycol di-(meth)acrylate, glycerol di-(meth)acrylate, 1,3-propanediol di-(meth)acrylate, 1,3-butane Diol di-(meth)acrylate, 1,4-butanediol di-(meth)acrylate, glycerol 1,3-diglycerate di-(meth)acrylate, ethylidene bis[ Oxy(2-hydroxypropane-1,3-diyl)]di-(meth)acrylate, bis[2-(meth)acrylooxyethyl]phosphate, trimethylolpropane di- (Meth)acrylate, and 3,4-bis[(meth)acryloyl]tetrahydrofuran, diacrylamide, dimethylacrylamide, N,N-di(meth)acryloyl-N -Methylamine, N,N-di(meth)acryloyl-N-ethylamine, N,N'-methylenebis(meth)acrylamide, N,N'-ethylidenebis(methyl)amine base) acrylamide, N,N'-dihydroxyethylidene bis(meth)acrylamide, N,N'-propylidene bis(meth)acrylamide, N,N'-2-hydroxyl Propylidene bis(meth)acrylamide, N,N'-2,3-dihydroxybutylene bis(meth)acrylamide, 1,3-bis(meth)acrylamide propane-2 - dihydrogen phosphate, piperazine diacrylamide, tetraethylene glycol divinyl ether, triethylene glycol divinyl ether, diethylene glycol divinyl ether, ethylene glycol divinyl ether, triethylene glycol divinyl ether Allyl isocyanurate, triallyl cyanurate, trimethylolpropane trimethacrylate, neotaerythritol tetramethacrylate, bisphenol A dimethacrylate, methyl Allyl acrylate, allyl acrylate, N-allyl-methacrylamide, N-allyl-acrylamide, and combinations thereof. The preferred non-silicone vinyl crosslinking agents are tetra(ethylene glycol) di-(meth)acrylate, tri(ethylene glycol) di-(meth)acrylate, ethylene glycol di-(meth)acrylate (Meth)acrylate, Di(ethylene glycol)di-(meth)acrylate, Tetraethylene glycol divinyl ether, Triethylene glycol divinyl ether, Diethylene glycol divinyl ether, Ethylene glycol Glycol divinyl ether, triallyl isocyanurate, triallyl cyanurate, and combinations thereof.

According to the present invention, any hydrophobic vinylic monomer can be used in the present invention. Examples of preferred preferred hydrophobic vinyl monomers include methyl (meth)acrylate, ethyl (meth)acrylate, propyl (meth)acrylate, isopropyl (meth)acrylate, (meth)acrylate base) cyclohexyl acrylate, 2-ethylhexyl (meth)acrylate, vinyl acetate, vinyl propionate, vinyl butyrate, vinyl valerate, styrene, chloroprene, vinyl chloride, vinylidene Dichloroethylene, (meth)acrylonitrile, 1-butene, butadiene, vinyltoluene, vinyl ethyl ether, perfluorohexylethyl-thio-carbonyl-aminoethyl-methacrylate, ( Isobornyl meth)acrylate, trifluoroethyl (meth)acrylate, hexafluoro-isopropyl (meth)acrylate, hexafluorobutyl (meth)acrylate, and combinations thereof.

Any thermal polymerization initiator can be used in the present invention. Suitable thermal polymerization initiators are known to the skilled person and include, for example, peroxides, hydroperoxides, azo-bis(alkyl- or cycloalkyl nitrile), persulfates, percarbonates or the like. mixture. Examples of preferred preferred thermal polymerization initiators include, but are not limited to, benzyl peroxide, tertiary butyl peroxide, tertiary amyl peroxybenzoate, 2,2-bis(tertiary butyl peroxide). oxy)butane, 1,1-bis(tertiarybutylperoxy)cyclohexane, 2,5-bis(tertiarybutylperoxy)-2,5-dimethylhexane, 2,5- Bis(tertiarybutylperoxy)-2,5-dimethyl-3-hexyne, bis(1-(tertiarybutylperoxy)-1-methylethyl)benzene, 1,1-bis (tertiary butylperoxy)-3,3,5-trimethylcyclohexane, ditertiary butyl-diperoxyphthalate, tertiary butyl hydroperoxide, tertiary peracetic acid Butyl ester, tertiary butyl peroxybenzoate, tertiary butyl peroxyisopropyl carbonate, acetyl peroxide, lauryl peroxide, decyl peroxide, dicetyl peroxydicarbonate, bis( 4-tertiary butylcyclohexyl) peroxydicarbonate (Perkadox 16S), bis(2-ethylhexyl) peroxydicarbonate, tertiary butyl peroxypivalate (Lupersol 11); tertiary Butyl peroxy-2-ethylhexanoate (Trigonox 21-C50), 2,4-pentanedione peroxide, dicumyl peroxide, peracetic acid, potassium persulfate, sodium persulfate, Ammonium persulfate, 2,2'-azobis(4-methoxy-2,4-dimethylvaleronitrile) (VAZO 33), 2,2'-azobis[2-(2-imidazoline -2-yl)propane] dihydrochloride (VAZO 44), 2,2'-azobis(2-amidinopropane) dihydrochloride (VAZO 50), 2,2'-azobis(2 ,4-dimethylvaleronitrile) (VAZO 52), 2,2′-azobis(isobutyronitrile) (VAZO 64 or AIBN), 2,2′-azobis-2-methylbutyronitrile ( VAZO 67), 1,1-azobis(1-cyclohexanecarbonitrile) (VAZO 88); 2,2'-azobis(2-cyclopropylpropanenitrile), 2,2'-azo Bis(methyl isobutyrate), 4,4'-azobis(4-cyanovaleric acid), and combinations thereof. Preferably, the thermal initiator is 2,2'-azobis(isobutyronitrile) (AIBN or VAZO 64).

Suitable photoinitiators are methyl benzoin, diethoxyacetophenone, benzalkonium phosphine oxide, 1-hydroxycyclohexyl phenyl ketone and Darocur and Irgacur types, preferably Darocur 1173® and Darocur 2959® , Norrish type I photoinitiators based on germanium (such as those described in US 7,605,190). Examples of benzylphosphine initiators include 2,4,6-trimethylbenzyldiphenylphosphine oxide; bis-(2,6-dichlorobenzyl)-4-N-propylbenzene and bis-(2,6-dichlorobenzyl)-4-N-butylphenylphosphine oxide. Also suitable are reactive photoinitiators, which can be incorporated into macromonomers or can be used as special monomers, for example. Examples of reactive photoinitiators are those disclosed in EP 632 329.

Examples of preferred preferred UV absorbing vinylic monomers and UV/HEVL absorbing vinylic monomers include, but are not limited to: 2-(2-hydroxy-5-vinylphenyl)-2H-benzotriazole azole, 2-(2-hydroxy-5-propenyloxyphenyl)-2H-benzotriazole, 2-(2-hydroxy-3-methacrylamidomethyl-5-tertiary octyl Phenyl)benzotriazole, 2-(2'-hydroxy-5'-methacrylamidophenyl)-5-chlorobenzotriazole, 2-(2'-hydroxy-5'-methyl) Acrylamidophenyl)-5-methoxybenzotriazole, 2-(2'-hydroxy-5'-methacryloyloxypropyl-3'-tert-butyl-phenyl) -5-Chlorobenzotriazole, 2-(2'-hydroxy-5'-methacryloyloxypropylphenyl)benzotriazole, 2-hydroxy-5-methoxy-3-( 5-(Trifluoromethyl)-2H-benzo[d][1,2,3]triazol-2-yl)benzyl methacrylate (WL-1), 2-hydroxy-5-methoxy yl-3-(5-methoxy-2H-benzo[d][1,2,3]triazol-2-yl)benzyl methacrylate (WL-5), 3-(5-fluoro -2H-benzo[d][1,2,3]triazol-2-yl)-2-hydroxy-5-methoxybenzyl methacrylate (WL-2), 3-(2H-benzene [d][1,2,3]triazol-2-yl)-2-hydroxy-5-methoxybenzyl methacrylate (WL-3), 3-(5-chloro-2H- Benzo[d][1,2,3]triazol-2-yl)-2-hydroxy-5-methoxybenzyl methacrylate (WL-4), 2-hydroxy-5-methoxy -3-(5-Methyl-2H-benzo[d][1,2,3]triazol-2-yl)benzyl methacrylate (WL-6), 2-hydroxy-5-methyl -3-(5-(trifluoromethyl)-2H-benzo[d][1,2,3]triazol-2-yl)benzyl methacrylate (WL-7), 4-allyl yl-2-(5-chloro-2H-benzo[d][1,2,3]triazol-2-yl)-6-methoxyphenol (WL-8), 2-{2'- Hydroxy-3'-tertiary-5'[3"-(4"-vinylbenzyloxy)propoxy]phenyl}-5-methoxy- 2H -benzotriazole, phenol, 2- (5-Chloro- 2H -benzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-vinyl-(UVAM), 2-[2'-hydroxy- 5'-(2-Methacryloyloxyethyl)phenyl)]-2H-benzotriazole (2-acrylic acid, 2-methyl-, 2-[3-( 2H -benzotriazole) -2-yl)-4-hydroxyphenyl]ethyl ester, Norbloc), 2-{2'-hydroxy-3'-tert-butyl-5'-[3'-methacryloyloxypropoxy ]phenyl} -2H -benzotriazole, 2-{2'-hydroxy-3'-tert-butyl-5'-[3'-methacryloyloxypropoxy]phenyl}-5 - Methoxy- 2H -benzotriazole (UV13), 2-{2'-hydroxy-3'-tert-butyl-5'-[3'-methacryloyloxypropoxy]phenyl} -5-Chloro- 2H -benzotriazole (UV28), 2-[2'-hydroxy-3'-tert-butyl-5'-(3'-propenyloxypropoxy)phenyl]- 5-Trifluoromethyl- 2H -benzotriazole (UV23), 2-(2'-hydroxy-5-methacrylamidophenyl)-5-methoxybenzotriazole (UV6), 2-(3-Allyl-2-hydroxy-5-methylphenyl)-2H-benzotriazole ( UV9 ), 2-(2-hydroxy-3-methylallyl-5-methyl) Phenyl)-2H-benzotriazole ( UV12 ), 2-3'-tert-butyl-2'-hydroxy-5'-(3"-dimethylvinylsilylpropoxy)-2' -Hydroxy-phenyl)-5-methoxybenzotriazole (UV15), 2-(2'-hydroxy-5'-methacryloylpropyl-3'-tert-butyl-phenyl) -5-Methoxy- 2H -benzotriazole (UV16), 2-(2'-hydroxy-5'-propenylpropyl-3'-tertiarybutyl-phenyl)-5-methoxy Base- 2H -benzotriazole (UV16A), 2-methacrylic acid 3-[3-tert-butyl-5-(5-chlorobenzotriazol-2-yl)-4-hydroxyphenyl] - Propyl ester (16-100, CAS#96478-15-8), 2-(3-(tertiarybutyl)-4-hydroxy-5-(5-methoxy-2H-benzo[d][ 1,2,3]Triazol-2-yl)phenoxy)ethyl methacrylate (16-102); phenol, 2-(5-chloro- 2H -benzotriazol-2-yl) -6-Methoxy-4-(2-propen-1-yl) (CAS#1260141-20-5); 2-[2-Hydroxy-5-[3-(methacryloyloxy)propyl ]-3-Tertiarybutylphenyl]-5-chloro- 2H -benzotriazole; Phenol, 2-(5-vinyl-2H-benzotriazol-2-yl)-4-methyl -, Homopolymer (9CI) (CAS# 83063-87-0). According to the present invention, the polymerizable composition comprises about 0.1% to about 3.0% by weight, preferably about 0.2% to about 2.5%, more preferably about 0.2% to about 2.5% by weight relative to all the polymerizable components in the polymerizable composition Preferred is from about 0.3% to about 2.0% of one or more UV absorbing vinylic monomers.

The term "UV/HEVL-absorbing vinylic monomer" refers to vinylic monomers that can absorb UV light and high-energy violet light (ie, light having a wavelength between 380 nm and 440 nm). Examples of UV absorbing vinylic monomers and UV/HEVL absorbing vinylic monomers are known to those skilled in the art and are disclosed in patents and patent application publications such as US 9,315,669, US 2018-0081197 A1, etc.

In the case where vinylic monomers capable of absorbing ultraviolet radiation and high energy violet light (HEVL) are used in the present invention, germane-based Norrish Type I photoinitiators and a range of about 400 to about 550 nm are included. The light source is preferably used to initiate free radical polymerization. Any germanium-based Norrish Type I photoinitiators can be used in the present invention as long as they are capable of initiating free radical polymerization under irradiation with a light source including light in the range of about 400 to about 550 nm. Examples of germane-based Norrish Type I photoinitiators are the acyl germanium compounds described in US 7,605,190.

A biologically active agent is any compound that can prevent eye disease or reduce symptoms of eye disease. Bioactive agents can be drugs, amino acids (eg, taurine, glycine, etc.), polypeptides, proteins, nucleic acids, or any combination thereof. Examples of drugs useful herein include, but are not limited to, rebamipide, ketotifen, olaptidine, cromoglycolate, cyclosporine, nedocromil, levothyroxine Carbastine, lodoxamide, ketotifen, or a pharmaceutically acceptable salt or ester thereof. Other examples of bioactive agents include 2-pyrrolidone-5-carboxylic acid (PCA), alpha hydroxy acids (eg, glycolic acid, lactic acid, malic acid, tartaric acid, mandelic acid, and citric acid and their salts, etc.), Linoleic and gamma linoleic acids, and vitamins (eg, B5, A, B6, etc.).

Examples of leachable lubricants include, but are not limited to, mucin-like materials (eg, polyglycolic acid) and non-crosslinkable hydrophilic polymers (ie, without ethylenically unsaturated groups). Any hydrophilic polymer or copolymer without any ethylenically unsaturated groups can be used as the leachable lubricant. Preferred examples of non-crosslinkable hydrophilic polymers include, but are not limited to, polyvinyl alcohol (PVA), polyamides, polyimides, polylactones, homopolymers of vinyllactams, with or without Copolymers of at least one vinyl lactamide, homopolymers of acrylamide or methacrylamide, acrylamide or methacrylamide in the presence of one or more hydrophilic vinylic comonomers and one or more Copolymers of hydrophilic vinyl monomers, polyethylene oxide (ie polyethylene glycol (PEG)), polyoxyethylene derivatives, poly-NN-dimethylacrylamide, polyacrylic acid, poly-2ethyl Oxazolines, heparin polysaccharides, polysaccharides, and mixtures thereof. The number average molecular weight _Mn of the non-crosslinkable hydrophilic polymer is preferably from 5,000 to 1,000,000.

Examples of leachable tear stabilizers include, but are not limited to, phospholipids, monoglycerides, diglycerides, triglycerides, glycolipids, glyceroglycolipids, sphingolipids, glycosphingolipids, fatty alcohols, fatty acids, mineral oils, and mixtures thereof . Preferably, the tear stabilizers are phospholipids, monoglycerides, diglycerides, triglycerides, glycolipids, glyceroglycolipids, sphingolipids, glycosphingolipids, fatty acids having 8 to 36 carbon atoms, Fatty alcohols of 36 carbon atoms, or mixtures thereof.

The polymerizable composition (SiHy lens formulation) can be prepared according to any known technique by dissolving all desired components in a polymeric non-reactive diluent and optionally one or more organic solvents (as described above)/ It is prepared by blending with it.

In a preferred preferred embodiment, the polymerizable composition (SiHy lens formulation) may contain at least one blended vinyl monomer as a reactive solvent to help dissolve the polymer non-reactive diluent in all other polymerizable in the polymeric component. Examples of preferred preferred blended vinyl monomers include C ₁ -C ₁₀ alkyl (meth)acrylates (eg, methyl (meth)acrylate, ethyl (meth)acrylate, (methyl) ) propyl acrylate, isopropyl (meth)acrylate, 2-ethylhexyl (meth)acrylate, pentyl (meth)acrylate, hexyl (meth)acrylate, etc.), cyclopentyl acrylate, Cyclohexyl methacrylate, cyclohexyl acrylate, isobornyl (meth)acrylate, styrene, 4,6-trimethylstyrene (TMS), tertiary butylstyrene (TBS), (methyl styrene) ) trifluoroethyl acrylate, hexafluoro-isopropyl (meth)acrylate, hexafluorobutyl (meth)acrylate, or a combination thereof. Preferably, methyl methacrylate is used as a blended vinyl monomer in preparing the polymerizable composition.

According to the present invention, the polymerizable composition is suitable for forming SiHy materials, which when fully hydrated can have from about 20% to about 70% by weight (preferably from about 20% to about 65%, more preferably is from about 25% to about 65%, even more preferably from about 30% to about 60%) water content. The polymerizable composition may comprise: (a) from about 20% to about 79% by weight (preferably from about 20% to about 75%, more preferably from about 25% to about 70%, Even more preferred is from about 30% to about 65%) of at least one silicone-containing vinylic monomer and/or at least one silicone-containing vinylic crosslinker; (b) 20% to about 65% by weight About 79% (preferably from about 20% to about 75%, more preferably from about 25% to about 70%, even more preferably from about 30% to about 65%) hydrophilic ethylene (c) from 0 to about 2.5% by weight (preferably from 0 to about 2.0%, more preferably from 0 to about 1.5%, even more preferably from about 0 to about 1.0%) of a non-silicone vinylic crosslinker; (d) from about 0.05% to about 2.0% by weight (preferably from about 0.1% to about 2.0%, more preferably from about 0.2% by weight) % to about 1.5%, even more preferably from about 0.3% to about 1.2%) of free radical initiators; (e) from 0 to about 15% by weight (preferably from 0 to about 14%) , more preferably from about 2% to about 13%, even more preferably from about 4% to about 12%) of the blended vinylic monomer; and (f) relative to the total polymerizable composition Amount by weight from 0 to about 3.0%, preferably from about 0.1% to about 2.5%, more preferably from about 0.2% to about 2.0% by weight of UV absorbing vinylic monomer and/or UV/HEVL absorbing vinyl monomers, provided that the sum of the amounts of polymerizable materials (a) to (f) and other components not listed is 100%. Preferably, the sum of the amount of polymerizable materials (a) and (b) is at least 70% by weight (preferably at least 75%, More preferably at least 80, even more preferably at least 85%).

Lens molds for making contact lenses are well known to those skilled in the art and are used, for example, in cast molding or spin casting. For example, a mold (for cast molding) typically includes at least two mold regions (or sections) or mold halves, a first and a second mold half. The first mold half defines a first molding (or optical) surface and the second mold half defines a second molding (or optical) surface. The first and second mold halves are configured to receive each other such that a lens-forming cavity is formed between the first molding surface and the second molding surface. The molding surface of the mold half is the cavity-forming surface of the mold and is in direct contact with the lens-forming material.

Almost all materials known in the art for making molds can be used to make molds for making contact lenses. For example, polymeric materials such as polyethylene, polypropylene, polystyrene, PMMA, ^Topas® COC grade 8007-S10 (from Tyrone, Frankfurt, Germany and Summit, New Jersey) can be used. Transparent amorphous copolymer of ethylene and norbornene from Ticona GmbH), etc. Other materials that allow transmission of UV light, such as quartz glass and sapphire, can be used.

Methods of making mold regions for cast molding contact lenses are generally well known to those skilled in the art. The method of the present invention is not limited to any particular method of forming a mold. In fact, any method of forming a mold can be used in the present invention. The first and second mold halves can be formed by various techniques such as injection molding or lathe machining. Examples of suitable methods for forming mold halves are disclosed in US Patent Nos. 4,444,711; 4,460,534; 5,843,346; and 5,894,002. However, for illustrative purposes, the following discussion is provided as one embodiment for forming a mold.

Typically, the mold includes at least two mold halves (or mold regions), a male mold half and a female mold half. The male mold half has a first molding (or optical) surface that is in direct contact with the polymerizable composition for cast molding the contact lens and defines a rear (or concave) surface for molding the contact lens; and the female mold half There is a second molding (or optical) surface that is in direct contact with the polymerizable composition and defines the front (or convex) surface of the molded contact lens. The male and female mold halves are configured to receive each other such that a lens-forming cavity is formed between the first molding surface and the second molding surface.

Figure 1 schematically illustrates a preferred mold 100 for use in the method of the present invention. The mold 100 includes a female mold half 1 and a male mold half 2 .

The male mold half 2 includes a base 61 , a generally cylindrical body 25 extending upwardly from the base 61 , a rear molding surface defining the rear (concave) surface of the molded contact lens, and an annular shoulder surrounding the rear molding surface 65 . The rear molding surface projects outwardly from the top of the body 25 . The annular shoulder 65 is shown flat. It will be appreciated that the annular shoulder 65 may have any suitable surface, such as, for example, a sloped surface.

The female mold half 1 includes a base 51 , a substantially cylindrical body 15 extending upwardly from the base 51 , a front molding surface defining the front (convex) surface of the molded contact lens, and a collar 4 . The front molding surface is concave downward from the top of the body 15 . The collar 4 (or upper flange) is preferably an integral part of the female mold half 1 and protrudes upwardly from the top of the body 15 . A circumferential groove (or depression) 11 is formed at the top of the body 15 , between the front molding surfaces and serves as an overflow area for any excess unpolymerized lens-forming material.

As used herein, the term "collar" refers to a peripheral circular portion that projects upwardly from the top of the body of one of the two mating mold halves. The collar may be attached to, or preferably be an integral part of, one mold half, and may wrap around the other mold half to provide a tight seal between the two mold halves. It should be understood that the collar may be provided on either of the male and female mold halves.

Female mold half 1 and male mold half 2 are configured to receive each other such that a contact lens forming cavity 12 is formed between the front and rear molding surfaces. The collar 4 surrounds the body 25 of the male mold half 2 to provide a tight seal 5 between the female and male mold halves when the mold is closed. Typically, no lens material is present in the seal.

In operation, the half-molds 1 and 2 may first be injection-moulded from plastic resin in an injection-moulding apparatus, as is well known to those skilled in the art. A specific amount of polymerizable lens-forming material is dispensed into the female mold half 1 , typically by a dispensing device, and then the male mold half 2 is placed and the mold 100 (FIG. 1) closed. When the mold 100 is closed, any excess unpolymerized lens-forming material is forced into the overflow region 11 provided on the female mold half 1 . It should be noted that the inserts or RGP discs are not shown in FIGS. 1 and 2 . Subsequently, the polymerizable composition in the closed mold 100 is thermally cured in an oven or actinically cured with UV/visible light irradiation.

The mold halves can be formed by various techniques such as injection molding. Methods of making mold halves for cast molding contact lenses are generally well known to those skilled in the art. The method of the present invention is not limited to any particular method of forming a mold. In fact, any method of forming a mold can be used in the present invention. The mold halves can be formed by various techniques such as injection molding or lathe machining. Examples of suitable methods for forming mold halves are disclosed in US Patent Nos. 4,444,711; 4,460,534; 5,843,346; and 5,894,002, which are also incorporated herein by reference.

Almost all materials known in the art for making molds can be used to make molds for making contact lenses. For example, polymeric materials such as polyethylene, polypropylene, polystyrene, PMMA, ^Topas® COC grade 8007-S10 (from Tyrone, Frankfurt, Germany and Summit, New Jersey) can be used. Transparent amorphous copolymer of ethylene and norbornene from Ticona GmbH), etc. Other materials that allow transmission of UV light, such as quartz glass and sapphire, can be used.

According to the present invention, any insert can be embedded in the embedded SiHy contact lens of the present invention as long as the insert is made of a non-hydrogel material and has a thickness less than any of the embedded SiHy contact lenses in the region where the insert is embedded thickness. The insert can be any object with any geometric shape and can have any desired function. Examples of preferred preferred inserts include, but are not limited to, thin RGP discs for providing rigid center optics to mask astigmatism, like RGP contact lenses, multifocal lens inserts, liquid meniscus lens inserts, electro Wetted Lens Inserts, Liquid Crystal Lens Inserts, Electroactive Lens Inserts, Electronics Inserts, Electrode Inserts, Battery Inserts, Antenna Inserts, Circuit Inserts, MEM Device Inserts, Sensor Inserts, Energy A receptor insert, a silicone rubber disc having at least one insert (any of those described above) embedded therein, having at least one insert (any of those described above) embedded therein The RGP disc, etc. The term "RGP" stands for rigid breathable. RGP thin discs refer to thin discs made of RGP material and optionally containing inserts.

According to the present invention, any RGP disc can be used to make the hybrid SiHy contact lens of the present invention, so long as the RGP disc has dimensions that ensure it becomes the overall central optic zone of the final hybrid SiHy contact lens product. It should be understood that RGP discs can also have inserts embedded therein. Examples of preferred preferred inserts include, but are not limited to, multifocal lens inserts, liquid meniscus lens inserts, electrowetting lens inserts, liquid crystal lens inserts, electro-active lens inserts, electronics inserts , electrode inserts, battery inserts, antenna inserts, circuit inserts, MEM device inserts, sensor inserts, energy receptor inserts, etc.

According to the present invention, the insert or the RGP disc can be placed in a mould and the polymerizable composition can be introduced (dispensed) into the cavity formed by the mould according to any known technique known to those skilled in the art . In a preferred preferred embodiment, the insert is placed at a designated location on the molding surface of the female mold half; and then a specified amount of polymerizable composition is dispensed by a dispensing device onto the insert with the insert thereon into the female half of the mold, and then put the male half on, and close the mold. When the mold is closed, any excess unpolymerized lens-forming material is pressed into the overflow zone provided on the female mold half (or alternatively the male mold half) and the insert is dipped into the polymerizable composition (or the RGP disc is surrounded by the molding surface and the polymerizable composition in the mold).

After placing the insert in the mold and dispensing the polymerizable composition into the mold, then thermally curing (ie, polymerizing) or actinically curing (but preferably thermally initiating) the closed mold containing the polymerizable composition to A raw embedded SiHy contact lens was formed.

The actinic polymerization of the polymerizable composition in the mold can be carried out by irradiating the closed mold with the polymerizable composition therein with UV or visible light according to any technique known to those skilled in the art.

Thermal polymerization of the polymerizable composition in the mold can be conveniently carried out in an oven at a temperature of from 25°C to 120°C and preferably 40°C to 100°C, as is well known to those skilled in the art. The reaction time may vary within wide limits, but is suitably for example from 1 to 24 hours or preferably from 2 to 12 hours. It is advantageous to degas the polymerizable composition beforehand and to carry out the copolymerization reaction under an inert atmosphere, for example under a _N2 or Ar atmosphere.

In a preferred preferred embodiment, after the polymerizable composition in the mold in the oven is cured to form a raw embedded or hybrid SiHy contact lens, the temperature of the oven is increased to about 105°C or higher (preferably is at least about 110ºC, more preferably at least about 115ºC, even more preferably at least about 120ºC), and the flow rate of nitrogen gas through the oven is increased to a second flow rate that is at least the first flow rate About 1.5 times (preferably at least about 2.0 times, more preferably at least about 3.0 times, even more preferably at least about 4.0 times).

The post-cure treatment step consists of heating the lens mold with the raw embedded or hybrid SiHy contact lens therein for at least about 30 minutes (preferably) at the post-cure temperature in the oven under a stream of nitrogen gas at a second flow rate through the oven. for at least about 60 minutes, more preferably at least about 90 minutes, even more preferably at least about 120 minutes).

After the curing step and, if necessary, the post-curing step, the mold is opened according to any technique known to those skilled in the art. For illustrative purposes, the following discussion is provided as opening the mold (ie, separating the male mold half from the female mold half, with a raw embedded or hybrid SiHy contact lens attached to one of the male and female mold halves) and One embodiment of delensing (ie, removal of a raw embedded or hybrid SiHy contact lens from the lens-adhered mold halves).

First, the non-optical surface of the negative mold is located at a position around the central region of the non-optical molding surface at less than about 30 degrees, preferably less than about 10 degrees, and most preferably less than about 5 degrees, relative to the axis of the mold degree angle (i.e., in a direction substantially normal to the central region of the non-optical molding surface) to apply a force to deform the female mold half, which destroys the optical molding surface of the female mold half and the molded lens. combination, as shown in Figure 2. There are different ways to apply a force along the axis of the mold to the non-optical surface of the female mold half at a location around the central region of the non-optical molding surface to deform the female mold half to destroy the optical molding surface of the female mold half and the molding Bonding between lenses. It will be appreciated that the mould opening means may have any configuration known to those skilled in the art to perform the function of separating the two mould halves from each other. For example, referring to Figure 2, the demold assembly includes a pin 70 that can be positioned against a central area of the non-optical molding surface of the female mold half. The pin 70 has a flat free end 70a to enable surface contact between the free end 70a and the central region of the non-optical molding surface of the female mold half. It should be understood that the scope of the present invention is not limited to this particular flat configuration of pin end 70a , for example the pin may have a rounded free end. In this embodiment, the pins 70 are movable and the female mold half is held stationary by applying a restraining force to the female mold half with the first prying fingers 32 to maintain the female mold half in a fixed position. However, the assembly can be arranged such that the female mold half is movable and the pin 70 remains stationary, or that both the pin 70 and the female mold half can move relative to each other.

In use, the free end 70a of the pin 70 applies a longitudinal force to the central portion of the non-optical surface of the female mold half during the demolding operation. The first prying fingers 32 apply a reaction force to the end face 51a of the flange 51 of the female mold half 1 . Thus, the female mold half is compressed between the free end 70a of the pin 70 and the first finger 32 . The compressive force deforms the curved portion of the female mold half and breaks the adhesive bond between the molding surface of the female mold half 1 and the front surface of the molded lens 12 .

Next, a second prying finger is used to apply a vertical lift movement to the male mold half, while maintaining constraints on the female mold to achieve a gradual separation between the female mold and the male mold.

After breaking the bond between the optical molding surface of the female mold half and the molded lens, the molds are separated and the raw embedded or hybrid SiHy contact lens is adhered to the male mold half 2 . It has been unexpectedly found that, in accordance with the present invention, even before or after dispensing a particular amount of polymerizable lens-forming material into one of the mold halves, the molding surfaces of the mold halves are not treated so that the mold halves are molded when the molds are separated. The contact lens is preferably adhered to the female or male mold, and the molded contact lens is adhered to the male mold half.

In accordance with the present application described above, the lens typically remains adhered to the area of the male mold. However, by using a similar principle, compression can be applied to apply a force along the longitudinal axis of the mold to the non-optical surface of the male mold half at a location around the central region of the non-optical molding surface to deform the male mold half to cause the pin The female mold half is compressed with the first set of prying fingers, thereby breaking the bond between the optical molding surface of the male mold half and the molded lens, whereby the molded lens adheres to the female mold half after the molds are separated .

According to the present invention, raw embedded or hybrid SiHy contact lenses are less soft and less brittle, and are dry-deliverable. The term "dry-deliverable" means that the processed embedded or hybrid SiHy contact lens can be mechanically removed directly from the lens-adhered mold halves (ie, by applying small forces to the unprocessed embedded or hybrid SiHy contact lens. without causing damage), or at most with the help of a cold air gun that blows cold air over the raw embedded or hybrid SiHy contact lens and/or the lens-adhered mold half.

After delensing the raw embedded or hybrid SiHy contact lens, it is typically extracted with an extraction medium as is well known to those skilled in the art. The extraction liquid medium is capable of dissolving one or more diluents, unpolymerized polymerizable materials, and oligomers in any solvent in the raw embedded or hybrid SiHy contact lens. Water, any organic solvent known to those skilled in the art, or mixtures thereof may be used in the present invention. Preferably, the organic solvent used as the extraction liquid medium is water, buffered saline, _{C1 -} C3 alkyl alcohol, 1,2-propanediol, polyethylene having a number average molecular weight of about 400 Daltons or less. Diols, _C1 - _C6 alkyl alcohols, or combinations thereof.

The extracted embedded or hybrid SiHy contact lenses can then be hydrated according to any method known to those skilled in the art.

Hydrated embedded or hybrid SiHy contact lenses can be further processed by other processes such as surface treatment, packaging in lens packaging with packaging solutions well known to those skilled in the art; sterilization, such as autoclaving from 118ºC to 124ºC for at least approx. 30 minutes; wait.

In another aspect, the present invention provides a raw embedded silicone hydrogel contact lens comprising a silicone hydrogel material, at least one insert, and a contact lens relative to the raw embedded silicone hydrogel The total weight of the lens is from about 0.5% to about 24% by weight (preferably from about 1.5% to about 19%, more preferably from about 2.5% to about 17%, even more preferably from about 3.5% to about 14%) of at least one polymeric non-reactive diluent, wherein the silicone hydrogel material has a polymeric matrix and comprises the following cross-linked materials: (a) at least one silicone-containing repeating units of vinylic monomers and/or at least one silicone-containing vinylic crosslinking agent and (b) repeating units of at least one hydrophilic vinylic monomer, wherein the insert is made of a non-hydrogel material and surrounded by the silicone hydrogel material, wherein the polymeric non-reactive diluent is distributed within the polymeric matrix of the silicone hydrogel material and comprises at least one poly(C ₂ -C ₄ alkylene oxide) A polymer wherein the raw silicone embedded hydrogel contact lens is capable of absorbing from about 15% to about 70% (preferably from about 15% to about 65%, more preferably from about 15% to about 65% by weight when fully hydrated) is from about 20% to about 65%, even more preferably from about 25% to about 60%) water. Preferably, the raw embedded silicone hydrogel contact lens has from about -7% to about 7% (preferably from about -5% to about 5%, more preferably from about - 3% to about 3%, even more preferably from about -1% to about 1%) water swellability.

In yet another aspect, the present invention provides a raw hybrid silicone hydrogel contact lens consisting essentially of two zones: a central optical zone made of a rigid breathable material; and a silicone hydrogel material A peripheral region (like a skirt) made and surrounding the central optic zone, and the raw hybrid silicone hydrogel contact lens comprises by weight relative to the total weight of the raw hybrid silicone hydrogel contact lens From about 0.25% to about 20% (preferably from about 1% to about 16%, more preferably from about 2.0% to about 12.5%, even more preferably from about 3.0% to about 10% %) of at least one polymeric non-reactive diluent, wherein the silicone hydrogel material has a polymeric matrix and comprises the following cross-linked materials: (a) at least one silicone-containing vinylic monomer and/or or at least one repeating unit of a silicone-containing vinylic crosslinking agent and (b) at least one repeating unit of a hydrophilic vinylic monomer, wherein the polymeric non-reactive diluent is distributed in the silicone hydrogel material. Within a polymer matrix and comprising at least one poly(C2 _{- C4} alkylene oxide) polymer, wherein the raw hybrid silicone hydrogel contact lens is capable of absorbing from about 10% by weight when fully hydrated to about 60% (preferably from about 15% to about 60%, more preferably from about 20% to about 60%, even more preferably from about 25% to about 55%) water. Preferably, the raw hybrid silicone hydrogel contact lens has from about -7% to about 7% (preferably from about -5% to about 5%, more preferably from about - 3% to about 3%, even more preferably from about -1% to about 1%) water swellability.

Including polymerizable compositions, silicone-containing vinyl monomers, silicone-containing vinyl crosslinkers, hydrophilic vinyl monomers, non-silicone vinyl crosslinkers, hydrophobic vinyl monomers, UV/ Water swellability of HEVL absorbent vinylic monomers, blended vinylic monomers, inserts, RGP discs, polymeric non-reactive diluents, raw embedded or hybrid silicone hydrogel contact lenses, and embedded All of the various embodiments of the preferred embodiments of the balanced water content of the hybrid silicone hydrogel contact lens may be incorporated into both aspects of the invention.

Although various embodiments of the present invention have been described using specific terms, devices, and methods, such descriptions are for illustration purposes only. The words used are descriptive and not restrictive. As should be apparent to those skilled in the art, many variations and modifications of the present invention can be made by those skilled in the art without departing from the spirit and scope of the novel concepts of the present disclosure. Furthermore, it should be understood that aspects of the various embodiments of the present invention may be interchanged in whole or in part or may be combined and/or used together in any manner, as described below:

1. A method for producing an embedded or hybrid silicone hydrogel contact lens, wherein each embedded silicone hydrogel contact lens has at least one insert embedded therein, wherein each hybrid silicone hydrogel contact lens Consisting essentially of a central optical zone of rigid gas permeable material and a peripheral zone of silicone hydrogel material surrounding the central optical zone, the method comprises the steps of: (1) obtaining a silicone hydrogel material for forming the A polymerizable composition, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 1% to about 25% by weight (preferably from about 2.0% to about 20%, more Preferably from about 3.0% to about 17.5%, even more preferably from about 4.0% to about 15%) of at least one polymeric non-reactive diluent and dissolved in (or with) the polymeric diluent blend) polymerizable material, wherein the polymerizable material comprises (a) at least one silicone-containing vinylic monomer and/or at least one silicone-containing vinylic crosslinking agent and (b) at least one hydrophilic vinyl type monomer, wherein the at least one polymeric non-reactive diluent comprises a poly(C ₂ -C ₄ alkylene oxide) polymer; (2) obtaining a lens mold, wherein the lens mold comprises a A male mold half and a female mold half having a second molding surface, wherein the male mold half and the female mold half are configured to receive each other such that when the mold is closed, the first and second molding surfaces are forming a mould cavity therebetween; (3) obtaining an insert or disc, wherein the insert is made of a non-hydrogel material, wherein the disc is made of a rigid gas permeable material and has a center with the first moulding surface an area-matching first surface and an opposing second surface that matches the central area of the second molding surface; (4) no specific order in which the insert or the disc is placed in the lens mold as specified position and introduce the polymerizable composition into the lens mold, wherein the insert is dipped into the polymerizable composition in the lens mold, wherein the disc is surrounded by the first and second molding surfaces and the lens A polymerizable composition in a mold surrounds; (5) curing the polymerizable composition in the lens mold to form a raw embedded or hybrid silicone hydrogel contact lens, wherein the raw embedded silicone hydrogel The contact lens has an insert surrounded by the silicone hydrogel material, wherein the raw hybrid silicone hydrogel contact lens consists essentially of a central optical zone of the rigid gas permeable material and the central optical zone surrounding the central optical zone The peripheral region composition of the silicone hydrogel material; (6) dividing the lens mold obtained in step (5) into male and female mold halves, wherein the raw embedded or hybrid silicone hydrogel contact lens is adhered On a lens-attached mold half, the lens-attached mold half being one of the male and female mold halves; (7) removing the raw embedded or hybrid silicone hydrogel contact lens from the lens-attached mold half; and (8) subjecting the raw embedded or hybrid silicone hydrogel contact lens to a post-molding process that includes hydration The process and one or more other processes selected from the group consisting of extraction, surface treatment, packaging, sterilization, and combinations thereof.

2. The method of embodiment 1, wherein the raw embedded or hybrid silicone hydrogel contact lens is mechanically removed from the lens-adhered mold half.

3. The method of embodiment 2, wherein the step of removing the raw embedded or hybrid silicone hydrogel contact lens from the lens-adhered mold half is performed by placing the raw embedded or hybrid silicone This is assisted by blowing cold air over the hydrogel contact lens and/or the mold half to which the lens is attached.

4. The method of any one of embodiments 1 to 3, wherein the step of curing the polymerizable composition in the lens mold is performed by irradiating the polymerizable composition with UV light or visible light in the mold. Actinically.

5. The method of any one of embodiments 1 to 3, wherein the step of curing the polymerizable composition in the lens mold is performed in an oven at a temperature of from 25ºC to 120ºC (preferably 40ºC to 100ºC). The temperature is heated for from about 1 to 24 hours.

6. The method of embodiment 5, wherein the curing step is performed under an inert atmosphere (eg, under a _N2 or Ar atmosphere).

7. The method of any one of embodiments 1 to 6, wherein the amount of the polymeric non-reactive diluent in the polymerizable composition is sufficient to provide a diluent having from about -7% to about 7%. The water swellability of the raw embedded silicone hydrogel contact lenses.

8. The method of any one of embodiments 1 to 6, wherein the amount of the polymeric non-reactive diluent in the polymerizable composition is sufficient to provide a diluent with from about -5% to about 5%. The water swelling degree of the raw embedded or hybrid silicone hydrogel contact lenses.

9. The method of any one of embodiments 1 to 6, wherein the amount of the polymeric non-reactive diluent in the polymerizable composition is sufficient to provide a diluent having from about -3% to about 3%. The water swelling degree of the raw embedded or hybrid silicone hydrogel contact lenses.

10. The method of any one of embodiments 1 to 6, wherein the amount of the polymeric non-reactive diluent in the polymerizable composition is sufficient to provide a diluent having from about -1% to about 1%. The water swelling degree of the raw embedded or hybrid silicone hydrogel contact lenses.

11. The method of any one of embodiments 1 to 10, wherein, in addition to the polymeric non-reactive diluent, the polymerizable composition comprises less than 10% by weight of any non-reactive diluent .

12. The method of any one of embodiments 1 to 10, wherein, in addition to the polymeric non-reactive diluent, the polymerizable composition comprises about 7.5% by weight or less of any non-reactive diluent Sexual thinner.

13. The method of any one of embodiments 1 to 10, wherein, in addition to the polymeric non-reactive diluent, the polymerizable composition comprises about 5.0% by weight or less of any non-reactive diluent Sexual thinner.

14. The method of any one of embodiments 1 to 10, wherein, in addition to the polymeric non-reactive diluent, the polymerizable composition comprises about 2.5% by weight or less of any non-reactive diluent Sexual thinner.

15. The method of any one of embodiments 11 to 14, wherein the non-reactive diluent other than the polymer non-reactive diluent is an organic solvent.

16. The method of embodiment 15, wherein the organic solvent is methanol, ethanol, 1-propanol, isopropanol, secondary butanol, tertiary butanol, tertiary amyl alcohol, acetone, methyl ethyl alcohol ketone, methyl isopropyl ketone, methyl propyl ketone, ethyl acetate, heptane, methyl hexane (various isomers), methylcyclohexane, dimethylcyclopentane (various isomers) compound), 2,2,4-trimethylpentane, or a mixture thereof.

17. The method of any one of embodiments 1 to 16, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 20% to about 79% by weight of all the The at least one silicone-containing vinyl monomer vinyl monomer and/or the at least one silicone-containing vinyl crosslinking agent vinyl crosslinking agent.

18. The method of any one of embodiments 1 to 16, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 20% to about 75% by weight of all the The at least one silicone-containing vinyl monomer vinyl monomer and/or the at least one silicone-containing vinyl crosslinking agent vinyl crosslinking agent.

19. The method of any one of embodiments 1 to 16, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 25% to about 70% by weight of all the The at least one silicone-containing vinyl monomer vinyl monomer and/or the at least one silicone-containing vinyl crosslinking agent vinyl crosslinking agent.

20. The method of any one of embodiments 1 to 16, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 30% to about 65% by weight of all the The at least one silicone-containing vinyl monomer vinyl monomer and/or the at least one silicone-containing vinyl crosslinking agent vinyl crosslinking agent.

21. The method of any one of embodiments 1 to 16, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from 20% to about 79% by weight of the hydrophilic Sexual vinyl monomers.

22. The method of any one of embodiments 1 to 16, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from 20% to about 75% by weight of the hydrophilic Sexual vinyl monomers.

23. The method of any one of embodiments 1 to 16, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 25% to about 70% by weight, or even More preferred is from about 30% to about 65% of the hydrophilic vinylic monomer.

24. The method of any one of embodiments 1 to 16, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 30% to about 65% by weight of the Hydrophilic vinyl monomer.

25. The method of any one of embodiments 1 to 24, wherein the polymerizable composition comprises from 0 to about 2.5 by weight (relative to the total weight of the polymerizable composition) of at least one non-silicon Ketone vinyl crosslinking agent.

26. The method of any one of embodiments 1 to 24, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from 0 to about 2.0% by weight of at least one non- Silicone vinyl crosslinker.

27. The method of any one of embodiments 1 to 24, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from 0 to about 1.5% by weight of at least one non- Silicone vinyl crosslinker.

28. The method of any one of embodiments 1 to 24, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 0 to about 1.0% by weight of at least one Non-silicone vinyl crosslinker.

29. The method of any one of embodiments 1 to 28, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from 0 to about 15% by weight of at least one Blending vinyl monomers, preferably wherein the at least one blending vinyl monomer system is methyl (meth)acrylate, ethyl (meth)acrylate, propyl (meth)acrylate, (meth)acrylate base) isopropyl acrylate, 2-ethylhexyl (meth)acrylate, pentyl (meth)acrylate, hexyl (meth)acrylate, cyclopentyl acrylate, cyclohexyl methacrylate, cyclohexyl Acrylate, isobornyl (meth)acrylate, styrene, 4,6-trimethylstyrene (TMS), tertiary butylstyrene (TBS), trifluoroethyl (meth)acrylate, (meth)acrylate base) hexafluoroisopropyl acrylate, hexafluorobutyl (meth)acrylate, or a combination thereof (more preferably, wherein the at least one blended vinyl monomer system methyl methacrylate).

30. The method of any one of embodiments 1 to 28, wherein the polymerizable composition comprises from 0 to about 14% by weight (relative to the total weight of the polymerizable composition) of at least one co-polymer Blended vinyl monomers, preferably wherein the at least one blended vinyl monomer system is methyl (meth)acrylate, ethyl (meth)acrylate, propyl (meth)acrylate, (methyl)acrylate ) Isopropyl acrylate, 2-ethylhexyl (meth)acrylate, pentyl (meth)acrylate, hexyl (meth)acrylate, cyclopentyl acrylate, cyclohexyl methacrylate, cyclohexyl acrylic acid ester, isobornyl (meth)acrylate, styrene, 4,6-trimethylstyrene (TMS), tertiary butylstyrene (TBS), trifluoroethyl (meth)acrylate, (methyl) ) hexafluoroisopropyl acrylate, hexafluorobutyl (meth)acrylate, or a combination thereof (more preferably, wherein the at least one blended vinyl monomer system methyl methacrylate).

31. The method of any one of embodiments 1 to 28, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 2% to about 13% by weight of at least A blended vinyl monomer, preferably wherein the at least one blended vinyl monomer is methyl (meth)acrylate, ethyl (meth)acrylate, propyl (meth)acrylate, (meth)acrylate Isopropyl meth)acrylate, 2-ethylhexyl (meth)acrylate, pentyl (meth)acrylate, hexyl (meth)acrylate, cyclopentyl acrylate, cyclohexyl methacrylate, cyclohexyl acrylate Hexyl acrylate, isobornyl (meth)acrylate, styrene, 4,6-trimethylstyrene (TMS), tertiary butylstyrene (TBS), trifluoroethyl (meth)acrylate, ( Hexafluoroisopropyl meth)acrylate, hexafluorobutyl (meth)acrylate, or a combination thereof (more preferably, wherein the at least one blended vinyl monomer system methyl methacrylate).

32. The method of any one of embodiments 1 to 28, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 4% to about 12% by weight of at least A blended vinyl monomer, preferably wherein the at least one blended vinyl monomer is methyl (meth)acrylate, ethyl (meth)acrylate, propyl (meth)acrylate, (meth)acrylate Isopropyl meth)acrylate, 2-ethylhexyl (meth)acrylate, pentyl (meth)acrylate, hexyl (meth)acrylate, cyclopentyl acrylate, cyclohexyl methacrylate, cyclohexyl acrylate Hexyl acrylate, isobornyl (meth)acrylate, styrene, 4,6-trimethylstyrene (TMS), tertiary butylstyrene (TBS), trifluoroethyl (meth)acrylate, ( Hexafluoroisopropyl meth)acrylate, hexafluorobutyl (meth)acrylate, or a combination thereof (more preferably, wherein the at least one blended vinyl monomer system methyl methacrylate).

33. The method of any one of embodiments 1 to 32, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from 0 to about 3.0% by weight of at least one UV Absorbing vinylic monomer and/or at least one UV/HEVL absorbing vinylic monomer.

34. The method of any one of embodiments 1 to 32, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 0.1% to about 2.5% by weight of at least One UV absorbing vinylic monomer and/or at least one UV/HEVL absorbing vinylic monomer.

35. The method of any one of embodiments 1 to 32, wherein the polymerizable composition comprises (relative to the total weight of the polymerizable composition) from about 0.2% to about 2.0% by weight of at least One UV absorbing vinylic monomer and/or at least one UV/HEVL absorbing vinylic monomer.

36. The method of any one of embodiments 1 to 35, wherein the sum of the amounts of polymerizable materials (a) and (b) is based on the total amount of all polymerizable materials in the polymerizable composition. At least 70% by weight.

37. The method of any one of embodiments 1 to 35, wherein the sum of the amounts of polymerizable materials (a) and (b) is based on the total amount of all polymerizable materials in the polymerizable composition. At least 75%, more preferably at least 80, even more preferably at least 85% by weight.

38. The method of any one of embodiments 1 to 35, wherein the sum of the amounts of polymerizable materials (a) and (b) is based on the total amount of all polymerizable materials in the polymerizable composition. At least 80, even more preferably at least 85% by weight.

39. The method of any one of embodiments 1 to 35, wherein the sum of the amounts of polymerizable materials (a) and (b) is relative to the total amount of all polymerizable materials in the polymerizable composition At least 85% by weight.

40. A raw embedded silicone hydrogel contact lens comprising: a silicone hydrogel material; at least one insert; and by weight relative to the total weight of the raw embedded silicone hydrogel contact lens From about 0.5% to about 24% of at least one polymeric non-reactive diluent, wherein the silicone hydrogel material has a polymeric matrix and comprises the following cross-linked materials: (a) at least one silicone-containing vinyl monomers vinyl monomers and/or at least one repeating unit of a silicone-containing vinyl crosslinking agent vinyl crosslinking agent and (b) repeating units of at least one hydrophilic vinyl monomer, wherein the insert made of and surrounded by a non-hydrogel material, wherein the at least one polymeric non-reactive diluent is distributed within a polymer matrix of the silicone hydrogel material and comprises poly( C2 _{- C4} alkylene oxide) polymer, wherein the raw silicone embedded hydrogel contact lens is capable of absorbing from about 15% to about 70% by weight water when fully hydrated, wherein, The raw silicone embedded hydrogel contact lens has a water swellability of from about -7% to about 7%.

41. The raw silicone-embedded hydrogel contact lens of embodiment 40, comprising from about 1.5% to about 19% by weight relative to the total weight of the raw silicone-embedded hydrogel contact lens % of at least one polymeric non-reactive diluent.

42. The raw silicone-embedded hydrogel contact lens of embodiment 40, comprising from about 2.5% to about 17% by weight relative to the total weight of the raw silicone-embedded hydrogel contact lens % of at least one polymeric non-reactive diluent.

43. The raw silicone-embedded hydrogel contact lens of embodiment 40, comprising from about 3.5% to about 14% by weight relative to the total weight of the raw silicone-embedded hydrogel contact lens % of at least one polymeric non-reactive diluent.

44. The raw silicone-embedded hydrogel contact lens of any one of embodiments 40-43, wherein the raw silicone-embedded hydrogel contact lens is capable of absorbing by weight when fully hydrated From about 15% to about 65% water.

45. The raw silicone-embedded hydrogel contact lens of any one of embodiments 40-43, wherein the raw silicone-embedded hydrogel contact lens is capable of absorbing by weight when fully hydrated From about 20% to about 65% water.

46. The raw silicone-embedded hydrogel contact lens of any one of embodiments 40-43, wherein the raw silicone-embedded hydrogel contact lens is capable of absorbing by weight when fully hydrated From about 25% to about 60% water.

47. The raw silicone-embedded hydrogel contact lens of any one of embodiments 40-46, wherein the raw silicone-embedded hydrogel contact lens preferably has from about -5 % to about 5% water swell.

48. The raw silicone-embedded hydrogel contact lens of any one of embodiments 40-46, wherein the raw silicone-embedded hydrogel contact lens has from about -3% to about 3 % water swelling.

49. The raw silicone-embedded hydrogel contact lens of any one of embodiments 40-46, wherein the raw silicone-embedded hydrogel contact lens has from about -1% to about 1 % water swelling.

50. A raw hybrid silicone hydrogel contact lens consisting essentially of two zones: a central optic zone made of a rigid breathable material; and a silicone hydrogel material surrounding the central optic zone The peripheral region (like the skirt), wherein the raw hybrid silicone hydrogel contact lens comprises from about 0.25% to about 0.25% by weight relative to the total weight of the raw hybrid silicone hydrogel contact lens 20% of at least one polymeric non-reactive diluent, wherein the silicone hydrogel material has a polymeric matrix and comprises the following cross-linked materials: (a) at least one silicone-containing vinyl monomer vinyl monomer and/or at least one repeating unit of a silicone-containing vinylic crosslinking agent and (b) at least one repeating unit of a hydrophilic vinylic monomer, wherein the at least one polymer is non-reactive diluting The agent is distributed within the polymer matrix of the silicone hydrogel material and comprises a poly(C2 _{- C4} alkylene oxide) polymer, wherein the raw hybrid silicone hydrogel contact lens is fully hydrated is capable of absorbing from about 10% to about 60% water by weight, wherein the raw hybrid silicone hydrogel contact lens has a water swellability of from about -7% to about 7%.

51. The raw hybrid silicone hydrogel contact lens of embodiment 50, wherein the raw hybrid silicone hydrogel contact lens comprises relative to the raw hybrid silicone hydrogel contact lens The total weight of the at least one polymeric non-reactive diluent is from about 1% to about 16% by weight.

52. The raw hybrid silicone hydrogel contact lens of embodiment 50, wherein the raw hybrid silicone hydrogel contact lens comprises relative to the raw hybrid silicone hydrogel contact lens The total weight of the at least one polymeric non-reactive diluent is from about 2.0% to about 12.5% by weight.

53. The raw hybrid silicone hydrogel contact lens of embodiment 50, wherein the raw hybrid silicone hydrogel contact lens comprises relative to the raw hybrid silicone hydrogel contact lens The total weight of the at least one polymeric non-reactive diluent is from about 3.0% to about 10% by weight.

54. The raw hybrid silicone hydrogel contact lens of any one of embodiments 50-53, wherein the raw hybrid silicone hydrogel contact lens is capable of absorbing by weight when fully hydrated From about 15% to about 60% water.

55. The raw hybrid silicone hydrogel contact lens of any one of embodiments 50-53, wherein the raw hybrid silicone hydrogel contact lens is capable of absorbing by weight when fully hydrated From about 20% to about 60% water.

56. The raw hybrid silicone hydrogel contact lens of any one of embodiments 50-53, wherein the raw hybrid silicone hydrogel contact lens is capable of absorbing by weight when fully hydrated From about 25% to about 55% water.

57. The raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 56, wherein the raw hybrid silicone hydrogel contact lens has from about -5% to about 5 % water swelling.

58. The raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 56, wherein the raw hybrid silicone hydrogel contact lens has from about -3% to about 3 % water swelling.

59. The raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 56, wherein the raw hybrid silicone hydrogel contact lens has from about -1% to about 1 % water swelling.

）的二價基團；PO係環氧丙烷（

）的二價基團；BO係環氧丁烷（

）的二價基團；m1係零或從5至65的整數；n1係零或從5至52的整數；p1係零或從5至30的整數；其中，如果n1不是零，則p1係零；其中，如果p1不是零，則n1係零且m1不是零；其中（m1+n1+p1）係提供具有以下數目平均分子量的該聚(C₂ -C₄ 伸烷基氧化物)聚合物的值：從約300至約3000道耳頓（較佳的是從約400至約2500道耳頓、更較佳的是從約400至約2000道耳頓、甚至更較佳的是從約400至約1500道耳頓）。60. The method of any one of embodiments 1-39, or the raw silicone-embedded hydrogel contact lens of any one of embodiments 40-49, or the method of any one of embodiments 50-59 The raw hybrid silicone hydrogel contact lens of any one, wherein at least one poly(C ₂ -C ₄ alkylene oxide) polymer is of the formula R ₁ -O-(EO) _m1 ( PO) _n1 (BO) _p1 -R ₂ represents, wherein: R ₁ and R ₂ are independently of each other hydrogen or C ₁ -C ₄ alkyl (preferably hydrogen or methyl); EO is ethylene oxide (

) of the divalent group; PO series propylene oxide (

) of the divalent group; BO series butylene oxide (

); m1 is zero or an integer from 5 to 65; n1 is zero or an integer from 5 to 52; p1 is zero or an integer from 5 to 30; wherein, if n1 is not zero, then p1 is zero; where, if p1 is not zero, then n1 is zero and m1 is not zero; where (m1+n1+p1) is to provide the poly(C2 _{- C4alkylene} oxide) polymer having the following number average molecular weight Value: from about 300 to about 3000 daltons (preferably from about 400 to about 2500 daltons, more preferably from about 400 to about 2000 daltons, even more preferably from about 400 to about 1500 Daltons).

61. The method of embodiment 60, or the raw embedded or hybrid silicone hydrogel contact lens of embodiment 60, wherein R1 and R2 are independently _of each other _hydrogen or methyl.

62. The method of embodiment 60 or 61, or the raw embedded or hybrid silicone hydrogel contact lens of embodiment 60 or 61, wherein the poly(C2 _- C4alkylene ₎ oxide) polymers have a number average molecular weight of from about 400 to about 2500 Daltons.

63. The method of embodiment 60 or 61, or the raw embedded or hybrid silicone hydrogel contact lens of embodiment 60 or 61, wherein the poly(C2 _- C4alkylene ₎ oxide) polymers have a number average molecular weight of from about 400 to about 2000 Daltons.

64. The method of embodiment 60 or 61, or the raw embedded or hybrid silicone hydrogel contact lens of embodiment 60 or 61, wherein the poly(C2 _- C4alkylene ₎ oxide) polymers have a number average molecular weight of from about 400 to about 1500 Daltons.

65. The method of any one of embodiments 1 to 39 and 60 to 64, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 61 to 64 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 64, wherein at least one poly(C ₂ -C ₄ alkylene oxide) polymer is a poly(cycloalkylene oxide) ethylene oxide) (“PEO”), poly(propylene oxide) (“PPO”), poly(ethylene oxide)-poly(propylene oxide) diblock copolymer (“PEO-PPO”), poly(ethylene oxide) (ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) triblock copolymer (“PEO-PPO-PEO”), poly(propylene oxide)-poly(ethylene oxide) - poly(propylene oxide) triblock copolymer ("PPO-PEO-PPO"), poly(ethylene oxide)-poly(butylene oxide) diblock copolymer ("PEO-PBO"), Poly(ethylene oxide)-poly(butylene oxide)-poly(ethylene oxide) triblock copolymer (“PEO-PBO-PEO”), poly(butylene oxide)-poly(epoxyethylene) ethane)-poly(butylene oxide) triblock copolymer ("PBO-PEO-PBO"), or mixtures thereof.

66. The method of any one of embodiments 1 to 39 and 60 to 64, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 64 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 64, wherein at least one poly(C ₂ -C ₄ alkylene oxide) polymer is a poly(cycloalkylene oxide) oxypropane) (“PPO”).

67. The method of any one of embodiments 1 to 39 and 60 to 64, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 64 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 64, wherein at least one poly(C ₂ -C ₄ alkylene oxide) polymer is a poly(cycloalkylene oxide) ethylene oxide)-poly(butylene oxide) diblock copolymer ("PEO-PBO"), poly(ethylene oxide)-poly(butylene oxide)-poly(ethylene oxide) triblock Block copolymer (“PEO-PBO-PEO”), poly(butylene oxide)-poly(ethylene oxide)-poly(butylene oxide) triblock copolymer (“PBO-PEO-PBO”) , or a mixture thereof.

68. The method of any one of embodiments 1 to 39 and 60 to 64, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 64 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 64, wherein at least one poly(C ₂ -C ₄ alkylene oxide) polymer is a poly(cycloalkylene oxide) ethylene oxide)-poly(propylene oxide) diblock copolymer ("PEO-PPO"), poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) triblock copolymer ("PEO-PPO-PEO"), poly(propylene oxide)-poly(ethylene oxide)-poly(propylene oxide) triblock copolymer ("PPO-PEO-PPO"), or mixtures thereof .

69. The method of any one of embodiments 1 to 39 and 60 to 64, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 64 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 64, wherein at least one poly(C ₂ -C ₄ alkylene oxide) polymer is a poly(cycloalkylene oxide) oxyethane).

70. The method of any one of embodiments 1 to 39 and 60 to 68, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 68 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 68, wherein the at least one silicone-containing vinyl monomer vinylic monomer system has a bis(trioxane) vinylsilyloxy) alkylsilyl or tris(trialkylsilyloxy)silyl vinyl monomers, polysiloxane vinyl monomers, polycarbosiloxane vinyl monomers, 3- Methacryloyloxypropyl pentamethyldisiloxane, tertiary butyldimethyl-siloxyethyl vinyl carbonate, trimethylsilylethyl vinyl carbonate, trimethylsilyl methyl vinyl carbonate, or a combination thereof, wherein the at least one silicone-containing vinyl monomer vinyl monomer system polysiloxane vinyl crosslinking agent, polycarbosiloxane vinyl crosslinking agent , or a combination thereof.

71. The method of any one of embodiments 1 to 39 and 60 to 69, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 69 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 69, wherein the at least one hydrophilic vinylic monomer comprises an alkyl(meth)acrylamide, Hydroxyl-containing acrylic monomers, amine-containing acrylic monomers, carboxyl-containing acrylic monomers, N-vinylamide monomers, methylene-containing pyrrolidone monomers, with C ₁ -C ₄ alkoxy Ethoxylated acrylic monomers, vinyl ether monomers, allyl ether monomers, phosphocholine-containing vinyl monomers, N-2-hydroxyethyl vinyl carbamate, N- Carboxyvinyl-beta-alanine (VINAL), N-carboxyvinyl-alpha-alanine, or a combination thereof.

72. The method of any one of embodiments 1 to 39 and 60 to 69, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 69 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 53 to 69, wherein the at least one hydrophilic vinylic monomer comprises (meth)acrylamide, N, N-Dimethyl (meth) acrylamide, N-ethyl (meth) acrylamide, N,N-diethyl (meth) acrylamide, N-propyl (meth) acrylamide amine, N-isopropyl(meth)acrylamide, N-3-methoxypropyl(meth)acrylamide, or a combination thereof.

73. The method of any one of embodiments 1 to 39 and 60 to 69, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 69 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 69, wherein the at least one hydrophilic vinylic monomer comprises N-2-hydroxyethyl (methyl ) acrylamide, N,N-bis(hydroxyethyl)(meth)acrylamide, N-3-hydroxypropyl(meth)acrylamide, N-2-hydroxypropyl(meth)propylene amide, N-2,3-dihydroxypropyl (meth)acrylamide, N -tris(hydroxymethyl)methyl(meth)acrylamide, 2-hydroxyethyl (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, glycerol methacrylate (GMA), di(ethylene glycol)(meth)acrylate, tri(ethylene glycol) (Meth)acrylates, Tetra(ethylene glycol)(meth)acrylates, Poly(ethylene glycol)(meth)acrylates with number average molecular weights up to 1500, Number average molecular weights up to 1500 of poly(ethylene glycol) ethyl (meth) acrylamide, or a combination thereof.

74. The method of any one of embodiments 1 to 39 and 60 to 69, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 69 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 69, wherein the at least one hydrophilic vinylic monomer comprises N-vinylpyrrolidone (also known as , N-vinyl-2 - pyrrolidone), N-vinyl-3-methyl-2-pyrrolidone, N-vinyl-4-methyl-2-pyrrolidone, N-vinyl- 5-Methyl-2-pyrrolidone, N-vinyl-6-methyl-2-pyrrolidone, N-vinyl-3-ethyl-2-pyrrolidone, N-vinyl-4, 5-Dimethyl-2-pyrrolidone, N-vinyl-5,5-dimethyl-2-pyrrolidone, N-vinyl-3,3,5-trimethyl-2-pyrrolidine Ketones, N-vinylpiperidone (also known as N-vinyl-2-piperidinone), N-vinyl-3-methyl-2-piperidinone, N-vinyl-4-methyl -2-Piperidinone, N-vinyl-5-methyl-2-piperidinone, N-vinyl-6-methyl-2-piperidinone, N-vinyl-6-ethyl-2 -Piperidinone, N-vinyl-3,5-dimethyl-2-piperidinone, N-vinyl-4,4-dimethyl-2-piperidinone, N-vinylcaprolactone Amines (also known as N-vinyl-2-caprolactam), N-vinyl-3-methyl-2-caprolactam, N-vinyl-4-methyl-2-caprolactam Amine, N-vinyl-7-methyl-2-caprolactam, N-vinyl-7-ethyl-2-caprolactam, N-vinyl-3,5-dimethyl-2 -Caprolactam, N-vinyl-4,6-dimethyl-2-caprolactam, N-vinyl-3,5,7-trimethyl-2-caprolactam, N- Vinyl-N-methylacetamide, N-vinylformamide, N-vinylacetamide, N-vinylisopropylacetamide, N-vinyl-N-ethylacetamide, N-vinyl-N-ethylformamide, or a composition thereof (preferably N-vinylpyrrolidone, N-vinyl-N-methylacetamide, or a combination thereof).

75. The method of any one of embodiments 1 to 39 and 60 to 69, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 69 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 69, wherein the at least one hydrophilic vinylic monomer comprises C ₁ -C ₄ alkoxyethoxy bases, including but not limited to ethylene glycol methyl ether (meth)acrylate, di(ethylene glycol) methyl ether (meth)acrylate, tris(ethylene glycol) methyl ether (meth)acrylate , Tetrakis(ethylene glycol) methyl ether (meth)acrylates, _C1 - _C4 -alkoxy poly(ethylene glycol) (meth)acrylates with weight average molecular weights up to 1500, Methoxy-poly(ethylene glycol)ethyl(meth)acrylamides of number average molecular weight up to 1500, or combinations thereof.

76. The method of any one of embodiments 1 to 39 and 60 to 75, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 75 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 50-75, wherein the raw embedded or hybrid silicone hydrogel contact lens comprises at least one non-silicone vinyl repeating unit of a crosslinking agent, the non-silicone vinylic crosslinking agent is selected from the group consisting of: tetra(ethylene glycol) di-(meth)acrylate, tri(ethylene glycol) di-(methyl) ) acrylate, ethylene glycol di-(meth)acrylate, di(ethylene glycol) di-(meth)acrylate, tetraethylene glycol divinyl ether, triethylene glycol divinyl ether, diethylene glycol Ethylene glycol divinyl ether, ethylene glycol divinyl ether, triallyl isocyanurate, triallyl cyanurate, and combinations thereof.

77. The method of any one of embodiments 1 to 39 and 60 to 76, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 76 , where the insert is a thin RGP disc for providing rigid center optics to mask astigmatism, like RGP contact lenses, multifocal lens inserts, liquid meniscus lens inserts, electrowetting lens inserts, liquid crystal inserts Lens Inserts, Electroactive Lens Inserts, Electronics Inserts, Electrode Inserts, Battery Inserts, Antenna Inserts, Circuit Inserts, MEM Device Inserts, Sensor Inserts, Energy Receptor Inserts, with Inserts A silicone rubber disc having at least one insert therein, an RGP disc having at least one insert embedded therein, or a combination thereof.

78. The method of any one of embodiments 1 to 39 and 60 to 76, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 76 , wherein the insert has a thickness that is less than any thickness of the embedded silicone hydrogel contact lens in the region where the insert is embedded in the raw silicone hydrogel embedded contact lens.

79. The method of any one of embodiments 1 to 39 and 60 to 78, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 78 , wherein the insert is made of hard plastic, breathable material, soft plastic, silicone rubber or elastomer, quartz, glass, silicate material, ceramic, metal, metal oxide and carbon material.

80. The method of any one of embodiments 1 to 39 and 60 to 76, or the raw silicone embedded hydrogel contact lens of any one of embodiments 40 to 49 and 60 to 76 , or the raw hybrid silicone hydrogel contact lens of any one of embodiments 50 to 76, wherein the RGP disc comprises at least one insert selected from the group consisting of: a multifocal lens Inserts, Liquid Meniscus Lens Inserts, Electrowetting Lens Inserts, Liquid Crystal Lens Inserts, Electroactive Lens Inserts, Electronics Inserts, Electrode Inserts, Battery Inserts, Antenna Inserts, Circuit Inserts, MEM device inserts, sensor inserts, energy receptor inserts, and combinations thereof.

The above disclosure should enable those skilled in the art to practice the present invention. Various modifications, changes and combinations may be made to the various embodiments described herein. In order to enable readers to better understand its specific implementation and advantages, it is suggested to refer to the following examples. It is intended that the specification and examples be considered exemplary.

Example 1

Oxygen permeability measurement

Unless specified, determine the oxygen transmission rate (Dk/t), intrinsic (or edge-corrected) oxygen transmission coefficient (Dk) of contact lenses or contact lens materials or inserts or insert materials according to the procedures described in ISO 18369-4 _i or Dk _c ).

Balanced water content

The Equilibrium Water Content (EWC) of a contact lens is determined as follows.

The amount of water (expressed as weight percent) present in fully equilibrated hydrated hydrogel contact lenses in saline solution was determined at room temperature. After the lenses were blotted dry with the fabric, the lenses were quickly stacked and the lens stack was transferred to an aluminum pan on an analytical balance. The number of lenses for each sample disk is typically five (5). The hydration weight of the disc plus the lens is recorded. Cover the pan with aluminum foil. Place the pan in a laboratory oven at 100ºC ± 2ºC and dry for 16-18 hours. Remove the pan plus lenses from the oven and cool in a desiccator for at least 30 minutes. Remove individual pans from desiccator and remove aluminum foil. The pan plus the dried lens samples are weighed on an analytical balance. Repeat for all discs. The wet and dry weights of the lens samples can be calculated by subtracting the weight of the empty weighing pan.

Elastic Modulus

Use the MTS insight instrument to determine the elastic modulus of a material or contact lens. Contact lenses were first cut to 3.12 mm wide with a Precision Concept two-stage cutter. Five thickness values are measured over a 6.5 mm gauge length. Mount the strips on the instrument holder and submerge them in PBS (phosphate buffered saline) with temperature controlled at 21ºC ± 2ºC. Typically, a 5 N load cell is used for testing. A constant force and velocity is applied to the sample until the sample ruptures. Force and displacement data were collected by TestWorks software. The elastic modulus value, which is the slope or tangent of the stress versus strain curve close to zero elongation in the elastically deformed region, was calculated by the TestWorks software.

Determination of Hydrated Contact Lens Diameter

Figure 3 schematically illustrates typical lens dimensions typically determined by contact lens manufacturers. General dimensions include central thickness (CT) ( 110 ), anterior sagittal height (ASag) ( 120 ), posterior sagittal height (PSag) ( 140 ), base curve equivalent (base curve equivalent) ( BCE) ( 150 ), edge thickness (ET) ( 160 ), and diameter ( 180 ) (ie, chord). General lens dimensions can be measured in wet cells by using low coherence interference with the method described by Heidemana and Greivenkampin in their paper (Optical Engineering 55(3), 034106 (March 2016)) Instrumentation was similarly performed on fully hydrated contact lenses using a low coherence interferometer.

For measurements, a contact lens was mounted on the flat bottom surface of a wet cell filled with phosphate buffered saline, and a low coherence interferometer was placed at the geometric center using a motion controller. Interferometers measure material thickness based on reflections between surfaces of different materials. The center of the lens is determined by camera measurements.

The diameter is defined as the outermost edge of the lens viewed from above the lens. The edge points were fitted to an ellipse, and the diameter was calculated as the average of the diameter of the large and small ellipses. Typically, contact lenses have a highly circular diameter and a circular or oval fit will yield similar values. However, if the lens is slightly out of circle, an ellipse more accurately describes the shape of the contact lens diameter than a circle. The lens diameters of 3 to 10 contact lenses from a single batch of contact lenses were measured and averaged to obtain the average lens diameter of the batch of contact lenses.

Layered

Use an Optimec instrument or optical coherence tomography (OCT) to examine possible delamination of embedded hydrogel contact lenses.

Regardless of the evaluation method, contact lenses were staged at room temperature for a minimum of 12 hours after the autoclave run and before the delamination study.

After the desired staging time was met, fully hydrated contact lenses were placed in the "V" grid assembly of the Optimec instrument (Model JCF; OPTIMEC, UK). After securing the contact lens under gravity, carefully inspect the front view of the contact lens for any signs of a circular pattern. The layers appear as circular patterns in the Optimec image.

OCT (spectral domain optical coherence tomography; Telesto-II; Thorlabs) can also be used to study delamination. OCT allows non-invasive imaging of contact lenses to obtain high-resolution cross-sectional images. For this purpose, after meeting the minimum staging requirements, the contact lenses were removed from their blister and soaked in a PBS solution for a minimum of 30 min to equilibrate. The cuvette with the "V" shaped block feature was then approximately ¾ full with fresh PBS solution and the contact lenses were transferred to the cuvette using Q-tips. The "V" shape at the bottom of the cuvette will allow the lens to float freely, and the entire contact lens will be scanned in 10 degree increments. In the OCT images, the delamination appears as air pockets on the spacer surfaces of the insert and carrier.

example 2

This example illustrates how to control the water swell of a green SiHy contact lens while ensuring the dryness of the green SiHy contact lens by adding a polymeric non-reactive diluent to the polymerizable composition used to form the SiHy material De-lensing.

Contact Lens Formulation Composition

其中，υ1係從30至500的整數並且ω1係從1至75的整數，並且根據在美國專利案號10081697中描述的程序製備（Mn約為10.7 Kg/mol，OH含量約為1.8 meq/g）；34重量單位份的單丁基封端的單甲基丙烯醯氧基丙基封端的聚二甲基矽氧烷（M.W.600至800 g/mol，來自蓋勒斯特公司（Gelest））；40重量單位的N-乙烯基吡咯啶酮；10.2重量單位份的乙二醇甲基醚甲基丙烯酸酯；9重量單位份的甲基丙烯酸甲酯；0.3重量單位份的三乙二醇二甲基丙烯酸酯；0.1重量單位份的甲基丙烯酸烯丙酯；0.5重量單位份的Darocur 1173；和1重量單位份的三級戊醇。The base polymerizable composition used as a control lens formulation was prepared by blending all components in air at room temperature for 30-120 minutes using a magnetic stir plate and had the following composition: 6 weight unit parts of a compound having the formula ( A) Hydrophilized polydimethylsiloxane vinyl crosslinker

where υ1 is an integer from 30 to 500 and ω1 is an integer from 1 to 75, and was prepared according to the procedure described in US Patent No. 10081697 (Mn about 10.7 Kg/mol, OH content about 1.8 meq/g ); 34 parts by weight of monobutyl-terminated monomethacrylooxypropyl-terminated polydimethylsiloxane (MW 600 to 800 g/mol from Gelest); 40 Weight unit of N-vinylpyrrolidone; 10.2 weight unit parts of ethylene glycol methyl ether methacrylate; 9 weight unit parts of methyl methacrylate; 0.3 weight unit parts of triethylene glycol dimethyl methacrylate Acrylate; 0.1 part by weight of allyl methacrylate; 0.5 part by weight of Darocur 1173; and 1 part by weight of tertiary pentanol.

The three polymerizable compositions as Formulations I-III were prepared by adding 10, 20 and 30 unit parts by weight of tertiary amyl alcohol (TAA) to the base polymer, respectively.

cast moulded SiHy contact lenses

Cast-molded SiHy contact lenses were prepared by charging each polypropylene contact lens mold with an amount of the formulation prepared above, and then using a double-sided UV curing oven (Wicked Engineering, Inc.) with an intensity of about 12 mW/cm2. , UV LED module 9W 365 nm/405 nm) prepared by curing for 15 minutes.

As shown in Figure 2 and as described above, the lens molds each having a molded raw SiHy contact lens were mechanically opened. For lenses made from Control Formulations and Formulation I only, the molded raw SiHy contact lenses were adhered to the male mold half and mechanically removed from the male mold half (ie, dry release of the lens). According to the procedure described in Example 1, the diameter of the dry delensated green SiHy contact lens (d _raw ) was determined.

The delensed raw SiHy contact lenses were then extracted and hydrated as follows. First, the raw SiHy contact lenses were extracted twice with a 50/50 v/v mixture of propylene glycol (PG) and deionized (DI) water for approximately one hour each. The extracted SiHy contact lenses were hydrated twice in DI water for approximately one hour each. After hydration, the diameter of the lens (ie, d- _hydration ) was determined according to the procedure described in Example 1.

The results of the tests and observations of dry detachment are reported in Table 1.

[Table 1] Formulation# TAA dry lens removal d _raw d _hydration WSD control 0.97 wt% Yes, no cold air gun is used 12.50 18.89mm 51.5% I 9.74 wt% Yes, no cold air gun is used 12.50 19.83 mm 57.4% II 17.09 wt% non-dry lens N/A N/A N/A III 23.33 wt% non-dry lens N/A N/A N/A

example 3

Contact Lens Formulation Composition

The four polymerizable compositions were prepared by blending all components in air at room temperature for 30-120 minutes using a magnetic stirring plate and had the following composition: 33 parts by weight units of CE-PDMS (Mn 6.5 KD) , which has a diurethane linkage between two polydimethylsiloxane (PDMS) segments and two urethane linkages each between a terminal methacrylate group and a PDMS segment 17 parts by weight of TrisAm (N-[tris(trimethylsiloxy)-silyl propyl] acrylamide); 24 parts by weight of DMA (N,N-dimethylacrylamide); 0.5 parts by weight of Darocur 1173; and 25 parts by weight of one of the 4 organic solvents (ethylene di alcohol butyl ether, tertiary amyl alcohol, isopropanol, and ethanol).

Cast-molded contact lenses were prepared by charging each polypropylene contact lens mold with an amount of the formulation prepared above and then using a double-sided UV curing oven with an intensity of about ¹² mW/cm (Wicked Engineering, Inc., UV LED module 9W 365 nm/405 nm) prepared by curing for 15 minutes.

As shown in Figure 2 and as described above, an attempt was made to mechanically open the lens molds each with a molded raw SiHy contact lens. Molded raw SiHy contact lenses are very sticky and fragile. As noted above, molded raw SiHy contact lenses are not dry-delivered, ie, cannot be mechanically removed directly from the lens-adhered male mold halves (ie, "delivered") even with the aid of a cold air gun.

Example 4

This example illustrates how to control the water swell of a green SiHy contact lens while ensuring the dryness of the green SiHy contact lens by adding a polymeric non-reactive diluent to the polymerizable composition used to form the SiHy material De-lensing.

Contact Lens Formulation Composition

The base polymerizable composition used as a control lens formulation was prepared by blending all components in air at room temperature for 30-120 minutes using a magnetic stir plate and had the following composition: 37.44 parts by weight units as in the Examples CE-PDMS (Mn 6.5 KD) as described in 3; 27.59 parts by weight of TrisAm (N-[tris(trimethylsiloxy)-silylpropyl]acrylamide); 33.50 parts by weight of DMA ( N,N-Dimethacrylamide); 0.49 parts by weight of neotaerythritol tetraacrylate; and 0.99 parts by weight of Darocur 819.

Prepared by adding 15, 20, 25 and 30 unit parts by weight of poly(propylene oxide) (Mn 425 from Sigma-Aldrich) ("PPO ₄₂₅ ") to the base polymer, respectively Four polymerizable compositions as formulations IV-VII.

cast moulded SiHy contact lenses

Cast-molded SiHy contact lenses were prepared by charging an amount of the formulation prepared above into each polypropylene contact lens mold, and then using a double-sided UV curing oven (Wicked Engineering) with an intensity of about ¹² mW/cm. Company, UV LED module 9W 365 nm/405 nm) prepared by curing for 15 minutes.

As shown in Figure 2 and as described above, the lens molds each having a molded raw SiHy contact lens were mechanically opened. Molded raw SiHy contact lenses were adhered to the male mold half. As described above, the molded raw SiHy contact lenses were mechanically removed (ie, "delivered") directly from the lens-adhered male mold halves, with or without the aid of a cold air gun. According to the procedure described in Example 1, the diameter of the dry delensated green SiHy contact lens (d _raw ) was determined.

The delensed raw SiHy contact lenses were then extracted and hydrated as follows. First, the raw SiHy contact lenses were extracted twice with a 50/50 v/v mixture of propylene glycol (PG) and deionized (DI) water for approximately one hour each. The extracted SiHy contact lenses were hydrated twice in DI water for approximately one hour each. After hydration, the diameter of the lens (ie, d- _hydration ) was determined according to the procedure described in Example 1.

The results of the tests and observations of dry detachment are reported in Table 2.

[Table 2] Formulation# PPO ₄₂₅ dry lens removal d _raw d _hydration WSD control 0 Yes, no cold air gun is used 12.50mm 13.50mm 8.0% IV 13.0 wt% Yes, no cold air gun is used 12.50mm 12.73 mm 1.8% V 16.7 wt% Yes, use a cold air gun 12.50mm 12.60mm 0.80% VI 20.0 wt% Yes, use a cold air gun 12.50mm 12.48mm -0.16% VII 25.9 wt% Yes, use a cold air gun 12.50mm 12.40mm -0.48%

Example 5

This example illustrates how the water swellability of green SiHy contact lenses can be controlled by adding a higher molecular weight polymeric non-reactive diluent to the polymerizable composition used to form the SiHy material, while ensuring that the green Dry de-lensability of SiHy contact lenses.

Contact Lens Formulation Composition

The base polymerizable composition as a control lens formulation was prepared as described in Example 4.

Prepared as Formulation _VIII- Four polymerizable compositions of XI.

cast moulded SiHy contact lenses

Cast molding, mold separation, delensing, extraction, and hydration of raw SiHy contact lenses were performed as described in Example 4.

According to the procedure described in Example 1, the diameter of the dry delensed raw SiHy contact lens ( _dunprocessed ) and the diameter of the hydrated SiHy contact lens (ie, _dhydrated ) were determined.

The results of the tests and observations of dry detachment are reported in Table 3.

[table 3] Formulation# PPO ₁₀₀₀ dry lens removal d _raw d _hydration WSD control 0 Yes, no cold air gun is used 12.50mm 14.30mm 14.4% VIII 13.0 wt% Yes, no cold air gun is used 12.50mm 13.45mm 7.6% IX 16.7 wt% Yes, use a cold air gun 12.50mm 13.00mm 4.0% X 20.0 wt% Yes, use a cold air gun 12.50mm 12.80mm 2.4% XI 25.9 wt% Yes, use a cold air gun 12.50mm 12.73 mm 1.8%

Example 6

This example illustrates how to make an embedded or hybrid SiHy contact lens with no or minimal lens distortion or delamination after extraction, hydration and autoclaving.

SiHy Lens Formulation Composition

The polymerizable composition (SiHy lens formulation) was prepared by blending all components in air at room temperature for 30-120 minutes using a magnetic stir plate and had the following composition: 32 parts by weight of the above Example 2 The hydrophilized polydimethylsiloxane ethylene-based crosslinking agent with formula (A) shown in (Mn is about 10.7 Kg/mol, OH content is about 1.8 meq/g); 24 parts by weight of N, N-Dimethacrylamide; 21 parts by weight of tris(trimethylsiloxy)silylpropyl methacrylate; 1.0 part by weight of Darocur 1173; and 22 parts by weight of PPO ₄₂₅ .

Cast-molded inserts SiHy contact lenses

Cast-molded SiHy-embedded contact lenses were prepared according to the procedure set forth in FIG. 4 . A first dose (approximately 3 µL) of the SiHy lens formulation was first added to each of the female polypropylene contact lens halves, each of which had three long spikes and three short spikes, the three The spikes are distributed on a circle with a diameter sufficient to accommodate the insert to fix the position of the insert on the molding surface, and the three short spikes are equally spaced from each other to support the insert on its molding surface. in the center position. A rigid gas permeable (RGP) insert was then placed on top of the first dose formulation in each female mold half, which was then pre-cured for 20 seconds. A second dose of the formulation was then added to the RGP insert to completely submerge the RGP insert. The mold was then closed with the male half and fully cured for 15 minutes using a double-sided UV curing oven (Wicked Engineering, UV LED Module 9W 365 nm/405 nm) with an intensity of about 12 mW/cm ² .

As shown in FIG. 2 and described above, the lens molds each having a molded raw embedded SiHy contact lens were mechanically opened. Molded raw embedded SiHy contact lenses were adhered to the male mold half. As described above, the molded raw embedded SiHy contact lenses were mechanically removed (ie, "delivered") directly from the lens-adhered male mold halves with or without the aid of a cold air gun. Raw embedded SiHy contact lenses were extracted with deionized (DI) water, first at 50ºC in the first DI water bath for two hours and then in the second DI water bath at 50ºC for one hour. The extracted embedded SiHy contact lenses were dipped (dip-coated) in an aqueous solution of polyacrylic acid (PAA, Mn about 450 KD) (0.1% by weight, pH about 2.5) at room temperature for two hours. The PAA-coated embedded SiHy contact lenses were immersed in phosphate-buffered saline (PBS) at room temperature (pH about 7.2 ± 0.2 at 25ºC, about 0.044 wt.% NaH ₂ PO ₄ ·H ₂ O, about 0.388 wt. % Na ₂ HPO ₄ ·2H ₂ O, and about 0.79 wt.% NaCl) for one hour. After rinsing in PBS, the coated SiHy embedded contact lenses were placed in polypropylene lens packaging housings (or blisters) with 0.6 mL of PBS (one lens per housing). The blister was then sealed with foil and autoclaved at about 121°C for about 45 minutes. .

The resulting embedded SiHy contact lenses were examined for possible delamination using OCT according to the procedure described in Example 1 . No delamination was observed. Embedded SiHy contact lenses were shown to have well-defined lens geometries after delensing, extraction, coating, hydration, and autoclaving (see Figure 5). Both the insert and bulk materials have minimal swelling ratios when hydrated, resulting in minimal internal stress, and thus good geometric stability over time.

cast moulded SiHy contact lenses

Cast-molded SiHy contact lenses were prepared by charging an amount of the ^SiHy lens formulation prepared above into each polypropylene contact lens mold and then using a double-sided UV curing oven (Wicked Engineering Company, UV LED module 9W 365 nm/405 nm) prepared by curing for 15 minutes.

Cast-molded SiHy contact lenses were demolded, demolded, extracted with DI water, dip-coated in aqueous PAA (0.1% by weight, pH about 2.5), Hydrate/rinse in PBS and pack/autoclave. The lens properties of the resulting SiHy contact lenses were determined according to the procedure described in Example 1 and reported in Table 4.

[Table 4] Lens characteristics Dk (Ball) 152 ± 3 Equilibrium water content (by weight) 31.0% Elastic modulus (MPa) 0.52

All publications, patents and patent application publications that have been cited herein above in this application are hereby incorporated by reference in their entirety.

1: Female mold half 2: Male mold half 4: Collar 5: Tight seal 11: Circumferential groove (or depression) 12: Molded lens 15: Body 25: Body 32: First prying finger 51: Base/ Flange 51a: End face of flange 51 61: Base 65: Annular shoulder 70: Pin 70a: Free end of pin 70 100: Die 110: Center thickness (CT) 120: Anterior sagittal height (ASag) ) 140: Posterior sagittal height (PSag) 150: Base curve equivalent (BCE) 160: Edge thickness (ET) 180: Diameter

[ Fig. 1 ] is a cross-sectional view of a mold according to a preferred embodiment of the present invention.

[FIG. 2] A process for separating male and female mold halves of a lens forming mold according to the present invention and an apparatus for carrying out the method of the present invention are schematically illustrated.

[Fig. 3] illustrates the general dimensions of a contact lens.

[FIG. 4] illustrates the casting molding procedure of the embedded SiHy contact lens according to the preferred embodiment of the present invention.

[Fig. 5] shows an OCT image of the embedded hydrogel contact lens produced according to the method of the present invention.

Claims (52)

A method for producing an embedded silicone hydrogel contact lens, wherein each embedded silicone hydrogel contact lens has at least one insert embedded therein, the method comprising the steps of: (1) obtaining a method for forming a silicone A polymerizable composition of a hydrogel material, wherein the polymerizable composition comprises from 1% to 25% by weight relative to the total weight of the polymerizable composition at least one polymer non-reactive diluent and dissolved in the A polymerizable material in or blended with a polymeric diluent, wherein the polymerizable material comprises (a) at least one silicone-containing vinylic monomer and/or at least one silicone-containing vinylic crosslinking agent and (b) ) at least one hydrophilic vinylic monomer, wherein the at least one polymeric non-reactive diluent comprises a poly(C2 _{- C4} alkylene oxide) polymer; (2) obtaining a lens mold, wherein the lens mold comprising a male mold half having a first molding surface and a female mold half having a second molding surface, wherein the male mold half and the female mold half are configured to receive each other such that when the mold is closed forming a cavity with the second molding surface; (3) obtaining an insert, wherein the insert is made of a non-hydrogel material; (4) placing the insert in the lens mold in no particular order Designating a location and introducing the polymerizable composition into the lens mold, wherein the insert is dipped into the polymerizable composition in the lens mold; (5) curing the polymerizable composition in the lens mold to form a Processed embedded silicone hydrogel contact lens, wherein the unprocessed embedded silicone hydrogel contact lens has an insert surrounded by the silicone hydrogel material; (6) combining the lens obtained in step (5) The mold is divided into male and female mold halves, wherein the raw embedded silicone hydrogel contact lens is adhered to the lens-adhered mold half, which is the one of the male mold and female mold halves. a; (7) removing the raw silicone embedded hydrogel contact lens from the mold half to which the lens is attached; and (8) subjecting the raw silicone embedded hydrogel contact lens to a post-molding process , which includes a hydration process and one or more other processes selected from the group consisting of extraction, surface treatment, packaging, sterilization, and combinations thereof. The method of claim 1 wherein the raw silicone-embedded hydrogel contact lens is mechanically removed from the lens-adhered mold half. The method of claim 2, wherein the step of removing the raw silicone-embedded contact lens from the lens-adhered mold half is performed by placing the raw silicone-embedded contact lens and / or blowing cold air over the mold half to which the lens is attached to assist. The method of claim 1, wherein the step of curing the polymerizable composition in the lens mold is performed actinically by irradiating the polymerizable composition with UV light or visible light in the mold. The method of claim 1, wherein the step of curing the polymerizable composition in the lens mold is performed thermally in an oven at a temperature of from 25°C to 120°C for from 1 to 24 hours. The method of claim 5, wherein the curing step is performed under an inert atmosphere. The method of any one of claims 1 to 6, wherein the amount of the polymeric non-reactive diluent in the polymerizable composition is sufficient to provide a water swellability of from -7% to 7% The raw embedded silicone hydrogel contact lens. The method of claim 7, wherein, in addition to the polymeric non-reactive diluent, the polymerizable composition comprises less than 10% by weight of any non-reactive diluent. The method of claim 8, wherein the polymerizable composition comprises: (i) from 20% to 79% by weight of the at least one silicone-containing Vinyl monomer and/or said at least one silicone-containing vinyl crosslinker; (ii) from 20% to 79% by weight of the hydrophilic vinyl, relative to the total weight of the polymerizable composition monomer; (iii) relative to the available The total weight of the polymerizable composition, from 0 to 2.5% by weight of at least one non-silicone vinylic crosslinking agent; (iv) relative to the total weight of the polymerizable composition, from 0 to 15% by weight of at least one A blended vinyl monomer, wherein the at least one blended vinyl monomer is methyl (meth)acrylate, ethyl (meth)acrylate, propyl (meth)acrylate, (meth)acrylic acid Isopropyl, 2-ethylhexyl (meth)acrylate, amyl (meth)acrylate, hexyl (meth)acrylate, cyclopentyl acrylate, cyclohexyl methacrylate, cyclohexyl acrylate, Isobornyl (meth)acrylate, styrene, 4,6-trimethylstyrene (TMS), tertiary butylstyrene (TBS), trifluoroethyl (meth)acrylate, (meth)acrylic acid Hexafluoroisopropyl, hexafluorobutyl (meth)acrylate, or a combination thereof. The method of claim 9, wherein the sum of the amounts of polymerizable materials (a) and (b) is at least 70% by weight relative to the total amount of all polymerizable materials in the polymerizable composition. The method of claim 10, wherein the at least one poly(C2 _{- C4alkylene} oxide) polymer is of the formula R1 _- O-(EO) _m1 (PO) _n1 (BO) _{p1 -} R2 Represents, wherein: R ₁ and R ₂ are independently of each other hydrogen or C ₁ -C ₄ alkyl; EO is a divalent group of ethylene oxide (-CH ₂ -CH ₂ -O-); PO is epoxy Propane (

) of the divalent group; BO series butylene oxide (

); m1 is zero or an integer from 5 to 65; n1 is zero or an integer from 5 to 52; p1 is zero or an integer from 5 to 30; wherein, if n1 is not zero, then p1 is zero; wherein, if p1 is not zero, then n1 is zero and m1 is not zero; wherein (m1+n1+p1) is to provide the poly(C2 _{- C4} alkylene oxide) polymer having the following number average molecular weight Value: from 300 to 3000 Daltons. The method of claim 11, wherein the at least one poly(C ₂ -C ₄ alkylene oxide) polymer is poly(ethylene oxide) ("PEO"), poly(propylene oxide) ("PPO"), poly(ethylene oxide)-poly(propylene oxide) diblock copolymers ("PEO-PPO"), poly(ethylene oxide)-poly(propylene oxide)-poly(epoxide ethylene) triblock copolymer ("PEO-PPO-PEO"), poly(propylene oxide)-poly(ethylene oxide)-poly(propylene oxide) triblock copolymer ("PPO-PEO- PPO"), poly(ethylene oxide)-poly(butylene oxide) diblock copolymer ("PEO-PBO"), poly(ethylene oxide)-poly(butylene oxide)-poly( ethylene oxide) triblock copolymer ("PEO-PBO-PEO"), poly(butylene oxide)-poly(ethylene oxide)-poly(butylene oxide) triblock copolymer ("PEO-PBO-PEO") PBO-PEO-PBO"), or a mixture thereof. The method of claim 11, wherein the at least one poly(C2 _{- C4alkylene} oxide) polymer is poly(propylene oxide) ("PPO"). The method of claim 11, wherein the at least one silicone-containing vinylic monomer system has bis(trialkylsilyloxy)alkylsilyl or tris(trialkylsilyloxy) Silicon-based vinyl monomer, polysiloxane vinyl monomer, polycarbosiloxane vinyl monomer, 3-methacryloyloxypropyl pentamethyldisiloxane, tertiary butyl disiloxane Methyl-siloxyethylvinylcarbonate, trimethylsilylethylvinylcarbonate, trimethylsilylmethylvinylcarbonate, or a combination thereof, wherein the at least one silicone-containing Vinyl monomer system polysiloxane vinyl crosslinking agent, polycarbosiloxane vinyl crosslinking agent, or a combination thereof; wherein the at least one hydrophilic vinyl monomer comprises alkyl (meth)propylene amide, hydroxyl-containing acrylic monomer, amine-containing acrylic monomer, carboxyl-containing acrylic monomer, N-vinyl amide monomer, methylene-containing pyrrolidone monomer, with C ₁ -C ₄ alkoxyethoxy acrylic monomers, vinyl ether monomers, allyl ether monomers, phosphocholine-containing vinyl monomers, N-2-hydroxyethyl vinyl carbamate , N-carboxyvinyl-beta-alanine (VINAL), N-carboxyvinyl-alpha-alanine, or a combination thereof. The method of claim 14, wherein the raw silicone embedded hydrogel contact lens comprises repeating units of at least one non-silicone vinylic crosslinking agent selected from the group consisting of Group: Tetra(ethylene glycol) di-(meth)acrylate, tri(ethylene glycol) di-(meth)acrylate, ethylene glycol di-(meth)acrylate, di(ethylene glycol) alcohol) di-(meth)acrylate, tetraethylene glycol divinyl ether, triethylene glycol divinyl ether, diethylene glycol divinyl ether, ethylene glycol divinyl ether, triallyl Isocyanurate, triallyl cyanurate, and combinations thereof. The method of claim 15, wherein the insert is a thin RGP disc, using For providing rigid center optics to mask astigmatism, like RGP contact lenses, multifocal lens inserts, liquid meniscus lens inserts, electrowetting lens inserts, liquid crystal lens inserts, electro-active lens inserts, electronics inserts inserts, electrode inserts, battery inserts, antenna inserts, circuit inserts, MEM device inserts, sensor inserts, energy receptor inserts, silicone rubber discs with at least one insert embedded therein, An RGP disc having at least one insert embedded therein, or a combination thereof. The method of claim 16, wherein the insert has a thickness that is less than any thickness of the embedded silicone hydrogel contact lens in the region where the insert is embedded in the unprocessed silicone hydrogel embedded contact lens. The method of claim 16, wherein the insert is made of hard plastic, breathable material, soft plastic, silicone rubber or elastomer, quartz, glass, silicate material, ceramic, metal, metal oxide and carbon material production. The method of claim 9, wherein the insert is a thin RGP disc for providing rigid central optics to mask astigmatism, like an RGP contact lens, wherein the RGP disc comprises at least one selected from the group consisting of Set of Inserts: Multifocal Lens Inserts, Liquid Meniscus Lens Inserts, Electrowetting Lens Inserts, Liquid Crystal Lens Inserts, Electroactive Lens Inserts, Electronics Inserts, Electrode Inserts, Battery Inserts, Antenna inserts, circuit inserts, MEM device inserts, sensor inserts, energy receptor inserts, and combinations thereof. A raw silicone embedded hydrogel contact lens comprising: a silicone hydrogel material; at least one insert; and from by weight relative to the total weight of the raw embedded silicone hydrogel contact lens 0.5% to 24% of at least one polymeric non-reactive diluent, wherein the silicone hydrogel material has a polymeric matrix and comprises the following cross-linked materials: (a) at least one silicone-containing vinyl monomer and/or repeating units of at least one silicone-containing vinylic crosslinking agent and (b) repeating units of at least one hydrophilic vinylic monomer, wherein the insert is made of a non-hydrogel material and is described Surrounded by a silicone hydrogel material, wherein the at least one polymeric non-reactive diluent is distributed within the polymeric matrix of the silicone hydrogel material and comprises a poly(C2 _{- C4} alkylene oxide) polymer material, wherein the raw embedded silicone hydrogel contact lens is capable of absorbing from 15% to 70% water by weight when fully hydrated, wherein the raw embedded silicone hydrogel contact lens has from -7 % to 7% water swelling. The raw silicone embedded hydrogel contact lens of claim 20, wherein the raw silicone embedded hydrogel contact lens is capable of absorbing from 15% to 60% by weight of water when fully hydrated . The raw silicone-embedded hydrogel contact lens of claim 21, wherein the at least one poly(C2 _{- C4alkylene} oxide) polymer is of the formula R1 _- O-(EO) _m1 ( PO) _n1 (BO) _p1 -R ₂ represents, wherein: R ₁ and R ₂ are independently of each other hydrogen or C ₁ -C ₄ alkyl; EO is ethylene oxide (-CH ₂ -CH ₂ -O-) The divalent group of ; PO is propylene oxide (

) of the divalent group; BO series butylene oxide (

); m1 is zero or an integer from 5 to 65; n1 is zero or an integer from 5 to 52; p1 is zero or an integer from 5 to 30; wherein, if n1 is not zero, then p1 is zero; wherein, if p1 is not zero, then n1 is zero and m1 is not zero; wherein (m1+n1+p1) is to provide the poly(C2 _{- C4} alkylene oxide) polymer having the following number average molecular weight Value: from 300 to 3000 Daltons. The raw silicone embedded hydrogel contact lens of claim 22, wherein the at least one poly(C2 _{- C4} alkylene oxide) polymer is poly(ethylene oxide) ("PEO" ), poly(propylene oxide) (“PPO”), poly(ethylene oxide)-poly(propylene oxide) diblock copolymer (“PEO-PPO”), poly(ethylene oxide)-poly(ethylene oxide) (propylene oxide)-poly(ethylene oxide) triblock copolymer (“PEO-PPO-PEO”), poly(propylene oxide)-poly(ethylene oxide)-poly(propylene oxide) triblock Block copolymers ("PPO-PEO-PPO"), poly(ethylene oxide)-poly(butylene oxide) diblock copolymers ("PEO-PBO"), poly(ethylene oxide)- Poly(butylene oxide)-poly(ethylene oxide) triblock copolymers ("PEO-PBO-PEO"), poly(butylene oxide)-poly(ethylene oxide)-poly(epoxyethylene) butane) triblock copolymer ("PBO-PEO-PBO"), or mixtures thereof. The raw silicone embedded hydrogel contact lens of claim 22, wherein the at least one poly(C2 _{- C4} alkylene oxide) polymer is poly(propylene oxide) ("PPO") . The raw silicone-embedded hydrogel contact lens of claim 22, wherein the at least one silicone-containing vinylic monomer system has a bis(trialkylsilyloxy)alkylsilyl group or Tris(trialkylsilyloxy)silyl vinyl monomers, polysiloxane vinyl monomers, polycarbosiloxane vinyl monomers, 3-methacryloyloxypropyl pentamethyl Disiloxane, tert-butyldimethyl-siloxyethyl vinyl carbonate, trimethylsilyl ethyl vinyl carbonate, trimethylsilyl methyl vinyl carbonate, or a combination thereof , wherein the at least one silicone-containing vinyl monomer system polysiloxane vinyl crosslinking agent, polycarbosiloxane vinyl crosslinking agent, or a combination thereof; wherein the at least one hydrophilic vinyl Monomers include alkyl (meth)acrylamides, hydroxyl-containing acrylic monomers, amine-containing acrylic monomers, carboxyl-containing acrylic monomers, N-vinyl amide monomers, methylene-containing pyrroles Peridone monomers, acrylic monomers with C ₁ -C ₄ alkoxyethoxy groups, vinyl ether monomers, allyl ether monomers, phosphocholine-containing vinyl monomers, N-2- Hydroxyethyl vinyl carbamate, N-carboxyvinyl-beta-alanine (VINAL), N-carboxyvinyl-alpha-alanine, or a combination thereof. The raw silicone embedded hydrogel contact lens of claim 25, wherein the raw silicone embedded hydrogel contact lens comprises at least one repeating unit of a non-silicone vinylic crosslinking agent, the non-silicone The ketone vinyl crosslinking agent is selected from the group consisting of: tetra(ethylene glycol) di-(meth)acrylate, tri(ethylene glycol) di-(meth)acrylate, ethylene glycol di-(meth)acrylate Meth)acrylate, di(ethylene glycol)di-(meth)acrylate, tetraethylene glycol divinyl ether, triethylene glycol divinyl ether, diethylene glycol divinyl ether, ethylene glycol Alcohol divinyl ether, triallyl isocyanurate, triene Propyl cyanurate, and combinations thereof. The raw silicone embedded hydrogel contact lens of claim 26, wherein the insert is a thin RGP disc for providing rigid center optics to mask astigmatism, like RGP contact lenses, multifocal lens inserts Inserts, Liquid Meniscus Lens Inserts, Electrowetting Lens Inserts, Liquid Crystal Lens Inserts, Electroactive Lens Inserts, Electronics Inserts, Electrode Inserts, Battery Inserts, Antenna Inserts, Circuit Inserts, MEMs A device insert, a sensor insert, an energy receptor insert, a silicone rubber disc having at least one insert embedded therein, an RGP disc having at least one insert embedded therein, or a combination thereof. The raw silicone-embedded hydrogel contact lens of claim 27, wherein the insert has a thickness that is less than the embedded silicone in the region where the insert is embedded in the raw silicone-embedded silicone hydrogel contact lens Keto hydrogel contact lenses of any thickness. The raw silicone embedded hydrogel contact lens of claim 27, wherein the insert is made of hard plastic, breathable material, soft plastic, silicone rubber or elastomer, quartz, glass, silicate material, Made of ceramics, metals, metal oxides and carbon materials. The raw silicone embedded hydrogel contact lens of claim 29, wherein the insert is a thin RGP disc for providing rigid central optics to mask astigmatism, like an RGP contact lens, wherein the RGP disc The disc contains at least one insert selected from the group consisting of: a multifocal lens insert, a liquid meniscus lens insert, an electrowetting lens insert, a liquid crystal lens insert, an electro-active lens insert, an electronics insert inserts, electrode inserts, battery inserts, antenna inserts, circuit inserts, MEM device inserts, sensor inserts, energy receptor inserts, and combinations thereof. A method for producing a hybrid silicone hydrogel contact lens, wherein each hybrid silicone hydrogel contact lens consists essentially of a central optic zone of rigid gas permeable material and a silicone hydrogel material surrounding the central optic zone (1) obtaining a polymerizable composition for forming a silicone hydrogel material, wherein the polymerizable composition comprises by weight relative to the total weight of the polymerizable composition From 1% to 25% of at least one polymeric non-reactive diluent and a polymerizable material dissolved in or blended with the polymeric diluent, wherein the polymerizable material comprises (a) at least one silicone-containing Vinyl monomer and/or at least one silicone-containing vinyl crosslinker and (b) at least one hydrophilic vinyl monomer, wherein the at least one polymeric non-reactive diluent comprises poly(C ₂ -C ₄ alkylene oxide) polymer; (2) obtaining a lens mold, wherein the lens mold comprises a male mold half having a first molding surface and a female mold half having a second molding surface, wherein the male mold half and female mould halves are configured to receive each other such that a mould cavity is formed between the first and second moulding surfaces when the mould is closed; (3) obtaining a disc, wherein the disc is made of the rigid gas permeable material (4) In no particular order, the disc is placing at a designated location in the lens mold, and introducing the polymerizable composition into the lens mold, wherein the disc is surrounded by the first and second molding surfaces and the polymerizable composition in the lens mold; (5) curing the polymerizable composition in the lens mold to form a green hybrid silicone hydrogel contact lens, wherein the green hybrid silicone hydrogel contact lens consists essentially of the rigid gas permeable material a central optical zone and a peripheral zone of the silicone hydrogel material surrounding the central optical zone; (6) dividing the lens mold obtained in step (5) into a male mold half and a female mold half, wherein the unprocessed mold The mixed silicone hydrogel contact lens is adhered to the lens-adhering mold half, which is one of the male mold half and the female mold half; (7) the unprocessed mixed silicone hydrogel The glue contact lens is removed from the mold half to which the lens is attached; and (8) the raw hybrid silicone hydrogel contact lens is subjected to a post-molding process including a hydration process and one or more selected from the group consisting of Other processes in the group: extraction, surface treatment, packaging, sterilization, and combinations thereof. The method of claim 31, wherein the raw hybrid silicone hydrogel contact lens is mechanically removed from the lens-adhered mold half. 32. The method of claim 32, wherein the step of removing the raw hybrid silicone hydrogel contact lens from the lens-adhered mold half is performed by placing the raw hybrid silicone hydrogel contact lens on the raw hybrid silicone hydrogel contact lens and / or blowing cold air over the mold half to which the lens is attached to assist. The method of claim 31, wherein the step of curing the polymerizable composition in the lens mold is performed actinically by irradiating the polymerizable composition with UV light or visible light in the mold. The method of claim 31, wherein the step of curing the polymerizable composition in the lens mold is performed thermally in an oven at a temperature of from 25°C to 120°C for from 1 to 24 hours. The method of claim 35, wherein the curing step is performed under an inert atmosphere. The method of any one of claims 31 to 36, wherein the amount of the polymeric non-reactive diluent in the polymerizable composition is sufficient to provide a polymer having a water swellability of from -7% to 7% The raw hybrid silicone hydrogel contact lens. The method of claim 37, wherein, in addition to the polymeric non-reactive diluent, the polymerizable composition comprises less than 10% by weight of any non-reactive diluent. The method of claim 38, wherein the polymerizable composition comprises: (i) from 20% to 79% by weight of the at least one silicone-containing Vinyl monomer and/or said at least one silicone-containing vinyl crosslinker; (ii) from 20% to 79% by weight of the hydrophilic vinyl, relative to the total weight of the polymerizable composition monomers; (iii) from 0 to 2.5 by weight of at least one non-silicone vinylic crosslinking agent relative to the total weight of the polymerizable composition; (iv) from 0 to 15% by weight of at least one blended vinylic monomer relative to the total weight of the polymerizable composition, wherein the at least one blended vinylic monomer is (meth)acrylic acid Methyl (meth)acrylate, propyl (meth)acrylate, isopropyl (meth)acrylate, 2-ethylhexyl (meth)acrylate, amyl (meth)acrylate, (meth)acrylate base) hexyl acrylate, cyclopentyl acrylate, cyclohexyl methacrylate, cyclohexyl acrylate, isobornyl (meth)acrylate, styrene, 4,6-trimethylstyrene (TMS), trimethyl acrylate tertiary butyl styrene (TBS), trifluoroethyl (meth)acrylate, hexafluoroisopropyl (meth)acrylate, hexafluorobutyl (meth)acrylate, or a combination thereof. The method of claim 39, wherein the sum of the amounts of polymerizable materials (a) and (b) is at least 70% by weight relative to the total amount of all polymerizable materials in the polymerizable composition. The method of claim 40, wherein the at least one poly(C2 _{- C4alkylene} oxide) polymer is of the formula R1 _- O-(EO) _m1 (PO) _n1 (BO) _{p1 -} R2 Represents, wherein: R ₁ and R ₂ are independently of each other hydrogen or C ₁ -C ₄ alkyl; EO is a divalent group of ethylene oxide (-CH ₂ -CH ₂ -O-); PO is epoxy Propane (

) of the divalent group; BO series butylene oxide (

); m1 is zero or an integer from 5 to 65; n1 is zero or an integer from 5 to 52; p1 is zero or an integer from 5 to 30; wherein, if n1 is not zero, then p1 is zero; wherein, if p1 is not zero, then n1 is zero and m1 is not zero; wherein (m1+n1+p1) is to provide the poly(C2 _{- C4} alkylene oxide) polymer having the following number average molecular weight Value: from 300 to 3000 Daltons. The method of claim 41, wherein the at least one poly(C ₂ -C ₄ alkylene oxide) polymer is poly(ethylene oxide) ("PEO"), poly(propylene oxide) ("PPO"), poly(ethylene oxide)-poly(propylene oxide) diblock copolymers ("PEO-PPO"), poly(ethylene oxide)-poly(propylene oxide)-poly(epoxide ethylene) triblock copolymer ("PEO-PPO-PEO"), poly(propylene oxide)-poly(ethylene oxide)-poly(propylene oxide) triblock copolymer ("PPO-PEO- PPO"), poly(ethylene oxide)-poly(butylene oxide) diblock copolymer ("PEO-PBO"), poly(ethylene oxide)-poly(butylene oxide)-poly( ethylene oxide) triblock copolymer ("PEO-PBO-PEO"), poly(butylene oxide)-poly(ethylene oxide)-poly(butylene oxide) triblock copolymer ("PEO-PBO-PEO") PBO-PEO-PBO"), or a mixture thereof. The method of claim 41, wherein the at least one poly(C2 _{- C4alkylene} oxide) polymer is poly(propylene oxide) ("PPO"). The method of claim 41, wherein the at least one silicone-containing vinylic monomer system has bis(trialkylsilyloxy)alkylsilyl or tris(trialkylsilyloxy) Silicon-based vinyl monomer, polysiloxane vinyl monomer, polycarbosiloxane vinyl monomer, 3-methacryloyloxypropyl pentamethyldisiloxane, tertiary butyl disiloxane Methyl-siloxyethylvinylcarbonate, trimethylsilylethylvinylcarbonate, trimethylsilylmethylvinylcarbonate, or a combination thereof, wherein the at least one silicone-containing Vinyl monomer system polysiloxane vinyl crosslinking agent, polycarbosiloxane vinyl crosslinking agent, or a combination thereof; wherein the at least one hydrophilic vinyl monomer comprises alkyl (meth)propylene amide, hydroxyl-containing acrylic monomer, amine-containing acrylic monomer, carboxyl-containing acrylic monomer, N-vinyl amide monomer, methylene-containing pyrrolidone monomer, with C ₁ -C ₄ alkoxyethoxy acrylic monomers, vinyl ether monomers, allyl ether monomers, phosphocholine-containing vinyl monomers, N-2-hydroxyethyl vinyl carbamate , N-carboxyvinyl-beta-alanine (VINAL), N-carboxyvinyl-alpha-alanine, or a combination thereof. The method of claim 44, wherein the raw hybrid silicone hydrogel contact lens comprises repeating units of at least one non-silicone vinylic crosslinking agent selected from the group consisting of Group: Tetra(ethylene glycol) di-(meth)acrylate, tris(ethylene glycol) di-(meth)acrylate, ethylene glycol di-(meth)acrylate, di(ethylene glycol) alcohol) di-(meth)acrylate, tetraethylene glycol divinyl ether, triethylene glycol divinyl ether, diethylene glycol divinyl ether, ethylene glycol divinyl ether, triallyl Isocyanurate, triallyl cyanurate, and combinations thereof. A raw hybrid silicone hydrogel contact lens consisting essentially of two zones: a central optic zone made of rigid breathable material; and a silicone hydrogel material surrounding the central optic zone A peripheral region of silicone hydrogel material, wherein the raw hybrid silicone hydrogel contact lens comprises from 0.25% to 20% by weight relative to the total weight of the raw hybrid silicone hydrogel contact lens % of at least one polymeric non-reactive diluent, wherein the silicone hydrogel material has a polymeric matrix and comprises the following cross-linked materials: (a) at least one silicone-containing vinylic monomer and/or at least one repeating unit of a silicone-containing vinylic crosslinker and (b) at least one repeating unit of a hydrophilic vinylic monomer, wherein the at least one polymeric non-reactive diluent is distributed in the silicone hydrogel Within and comprising a poly(C2 _{- C4} alkylene oxide) polymer within the polymer matrix of the material, wherein the raw hybrid silicone hydrogel contact lens is capable of absorbing from 10% by weight to 60% water, wherein the raw hybrid silicone hydrogel contact lens has a water swell from -7% to 7%. The raw hybrid silicone hydrogel contact lens of claim 46, wherein the raw hybrid silicone hydrogel contact lens is capable of absorbing from 15% to 60% by weight water when fully hydrated . The raw hybrid silicone hydrogel contact lens of claim 46, wherein the at least one poly(C2 _{- C4alkylene} oxide) polymer is of the formula R1 _- O-(EO) _m1 ( PO) _n1 (BO) _p1 -R ₂ represents, wherein: R ₁ and R ₂ are independently of each other hydrogen or C ₁ -C ₄ alkyl; EO is ethylene oxide (-CH ₂ -CH ₂ -O-) The divalent group of ; PO is propylene oxide (

) of the divalent group; BO series butylene oxide (

); m1 is zero or an integer from 5 to 65; n1 is zero or an integer from 5 to 52; p1 is zero or an integer from 5 to 30; wherein, if n1 is not zero, then p1 is zero; wherein, if p1 is not zero, then n1 is zero and m1 is not zero; wherein (m1+n1+p1) is to provide the poly(C2 _{- C4} alkylene oxide) polymer having the following number average molecular weight Value: from 300 to 3000 Daltons. The raw hybrid silicone hydrogel contact lens of claim 48, wherein at least one poly(C2 _{- C4} alkylene oxide) polymer is poly(ethylene oxide) ("PEO" ), poly(propylene oxide) (“PPO”), poly(ethylene oxide)-poly(propylene oxide) diblock copolymer (“PEO-PPO”), poly(ethylene oxide)-poly(ethylene oxide) (propylene oxide)-poly(ethylene oxide) triblock copolymer (“PEO-PPO-PEO”), poly(propylene oxide)-poly(ethylene oxide)-poly(propylene oxide) triblock Block copolymers ("PPO-PEO-PPO"), poly(ethylene oxide)-poly(butylene oxide) diblock copolymers ("PEO-PBO"), poly(ethylene oxide)- Poly(butylene oxide)-poly(ethylene oxide) triblock copolymers ("PEO-PBO-PEO"), poly(butylene oxide)-poly(ethylene oxide)-poly(epoxyethylene) butane) triblock copolymer ("PBO-PEO-PBO"), or mixtures thereof. The raw hybrid silicone hydrogel contact lens of claim 48, wherein the at least one poly(C2 _{- C4} alkylene oxide) polymer is poly(propylene oxide) ("PPO") . The raw hybrid silicone hydrogel contact lens of claim 51, wherein the at least one silicone-containing vinylic monomer system has a bis(trialkylsilyloxy)alkylsilyl group or Tris(trialkylsilyloxy)silyl vinyl monomers, polysiloxane vinyl monomers, polycarbosiloxane vinyl monomers, 3-methacryloyloxypropyl pentamethyl Disiloxane, tert-butyldimethyl-siloxyethyl vinyl carbonate, trimethylsilyl ethyl vinyl carbonate, trimethylsilyl methyl vinyl carbonate, or a combination thereof , wherein the at least one silicone-containing vinyl monomer system polysiloxane vinyl crosslinking agent, polycarbosiloxane vinyl crosslinking agent, or a combination thereof; wherein the at least one hydrophilic vinyl Monomers include alkyl (meth)acrylamides, hydroxyl-containing acrylic monomers, amine-containing acrylic monomers, carboxyl-containing acrylic monomers, N-vinyl amide monomers, methylene-containing pyrroles Peridone monomers, acrylic monomers with C ₁ -C ₄ alkoxyethoxy groups, vinyl ether monomers, allyl ether monomers, phosphocholine-containing vinyl monomers, N-2- Hydroxyethyl vinyl carbamate, N-carboxyvinyl-beta-alanine (VINAL), N-carboxyvinyl-alpha-alanine, or a combination thereof. The raw hybrid silicone hydrogel contact lens of claim 51, wherein the raw hybrid silicone hydrogel contact lens comprises at least one repeating unit of a non-silicone vinylic crosslinking agent, the non-silicone The ketone vinyl crosslinking agent is selected from the group consisting of: tetra(ethylene glycol) di-(meth)acrylate, tri(ethylene glycol) di-(meth)acrylate, ethylene glycol di-(meth)acrylate Meth)acrylate, di(ethylene glycol)di-(meth)acrylate, tetraethylene glycol divinyl ether, triethylene glycol divinyl ether, diethylene glycol divinyl ether, ethylene glycol Alcohol divinyl ether, triallyl isocyanurate, triallyl cyanurate, and combinations thereof.

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